CIPN - Chemotherapy-Induced Peripheral Neuropathy
Conditions
Brief summary
This pilot study will attempt to establish the feasibility of using tissue oxygen measurements and the protein, neurofilament light chain (NF-L), as potential biomarkers for chemotherapy-induced peripheral neuropathy (CIPN). Thirty (30) subjects scheduled to begin taxane-based chemotherapy for breast tumor will be assigned to receive an India ink injection under the skin of the foot. The ink will be used to make up to five (5) 45-minute electron paramagnetic resonance (EPR) oximetry readings prior to the start of chemotherapy. Subjects will undergo electrophysiologic assessments including nerve conduction studies, in addition to a neurological examination prior to the start of chemotherapy. Subjects will have the EPR oximetry readings, electrophysiologic tests, and neurological examination two more times: at the halfway point of their chemotherapy treatment -- or at the onset of CIPN symptoms -- and again after chemotherapy has been completed. Subjects will also have blood drawn prior to beginning taxane-based chemotherapy, prior to every scheduled chemotherapy treatment, and after completion of chemotherapy in order to test for neurofilament light chain (NF-L).
Detailed description
Therapy with chemotherapeutic drugs can make a huge impact on survival and quality of life in patients with cancer. Advances in medical monitoring and the effectiveness of these therapies have significantly improved outcomes so that a definitive cure or long-term survival is more likely. Cancer survivors are used to dealing with serious side effects of their therapy; however, some of the side effects from the chemotherapy drugs persist even after the medication course is completed. The impact of these sequelae on quality of survival is increasingly being appreciated and forming an important new direction of cancer care. One of the more severe side effects of chemotherapy is peripheral neurotoxicity resulting in neuropathy or neuronopathy. Chemotherapy-induced peripheral neurotoxicity (CIPN) is one of the least predictable and most prolonged sequelae with effects ranging from pain, numbness and tingling to diffuse weakness sometimes to the extent of paralysis. It results from damage or alteration in function of peripheral nerves usually, but not always, in a length-dependent manner. An indirect impact of CIPN includes difficulties with balance and susceptibility to falls. There are currently no therapies that have been proven to prevent CIPN. Similarly, there are few medications that are known to be effective in the reversing CIPN once it develops or effectively treating symptoms of CIPN. Currently, diagnosis is based mainly on clinical examination and electrophysiological testing to monitor CIPN; identification of candidate biomarkers through which disease onset can be identified at an earlier stage and which reflect presumed pathophysiologic mechanisms is of paramount importance. There are different theories of CIPN pathogenesis. One of the leading hypotheses relates to mitochondrial dysfunction and oxidative stress affecting both the dorsal root ganglia neurons and supportive endothelial cells of the vasa nervorum. Here at Dartmouth, a specialized technique has been developed that allows the non-invasive assessment of tissue oxygen in and around peripheral nerve. This technique, called electron paramagnetic resonance (EPR) oximetry, allows for repeated measurements over time that can be correlated with other metrics of peripheral nerve function. Given its relevance to an important pathophysiologic mechanism of disease, EPR oximetry may provide an early marker of disease onset. Neurofilament light chain (NF-L) is also emerging as a sensitive blood-based biomarker of axonal degeneration. NF-L is a component of the axonal cytoskeleton that leaks out of degenerating axons. NF-L has been reported to be elevated in plasma or serum in a wide range of neurodegenerative disorders, including CNS disorders such as multiple sclerosis and ALS as well as PNS disorders such as Charcot Marie Tooth and Guillain-Barre syndrome. To date, there are no published reports of elevated blood NF-L levels in patients with CIPN, although it has been reported to increase in rat model of vincristine-induced neuropathy. In this proposal, the investigators will be testing the hypothesis that these could both be biomarkers of CIPN. It is hoped that the oximetry measurement and blood NF-L levels will (i) reflect the changes that occur on a cellular level and the damaged nerves, (ii) reflect the damage occurring to nerves more sensitively than existing techniques, and (iii) help to better understand the reason the nerves are being damaged. It is also hoped that these will be something that can be used in future clinical trials.
Interventions
DIAGNOSTIC_TESTEPR Oximetry
Subjects will have up to five EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
Sponsors
Disarm Therapeutics
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled to receive chemotherapy with taxane compounds for the treatment of breast cancer. * No prior taxane or platinum chemotherapy prior to enrollment. * Life expectancy greater than or equal to 12 months. * Able to provide independent informed consent for the study. * Able to undergo EPR oximetry * Age 18 years or older
Exclusion criteria
* Central nervous system or other impairments that interfere with clinical and electrophysiological assessment. * Unable to provide independent informed consent. * Pacemaker or other metallic objects that would be contraindicated for MRI. * A requirement for supplemental oxygen at baseline, or known, severe chronic obstructive pulmonary disease . * Previous exposure to neurotoxic chemotherapeutic agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Change in % pO2 | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | EPR Oximetry will measure tissue oxygen levels in the injected foot during 10 minutes of breathing room air, 10 minutes while breathing 100% oxygen, and 10 minutes of room air. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nerve Conduction_Motor_ (Amplitude)_Tibial-AH | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
| Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP AMP, EDB | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
| Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP, AT | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
| Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Tibial CMAP, AH | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
| Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Dorsal Sural CV | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
| Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Med Plantar CV | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
| Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Sural CV | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
| Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CV, Distal | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
| Mean Score of Neuro-Quality of Life - Positive Affect and Well-Being Scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Neuropathy-Specific Quality of Life scale measuring Positive Affect and Well Being The range in score is 23 to 115, with a low score indicating a less positive affect and well-being |
| Mean Score of Neuro-Quality of Life - Satisfaction With Social Roles and Activities Scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Neuropathy-Specific Quality of Life scale measuring Satisfaction with Social Roles and Activities The range in scores is 47 to 235, with a lower score indicating less satisfaction with social roles and activities |
| Mean Score of Neuro-Quality of Life - Lower Extremity Function (Mobility) Scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Neuropathy-Specific Quality of Life scale measuring Lower Extremity Function (Mobility) The range in scores is 19 to 95, with a lower score indicating more difficulty with lower extremity function |
| Mean Score of Neuro-Quality of Life - Upper Extremity Function (Fine Motor, Activities of Daily Living) Scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Neuropathy-Specific Quality of Life scale measuring Upper Extremity Function (Fine Motor, Activities of Daily Living) The range in scores is 20 to 100, with a low score indicating more difficulty with upper extremity function |
| Mean Score of The Neuropathy Total Symptom Score-6 Questionnaire | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Neuropathy Total Symptom Score questionnaire with 6 questions The range is scores is 0 to 22 with a higher score indicating worse symptoms |
| Mean Score of Toronto Clinical Neuropathy Scoring System | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Toronto Clinical Neuropathy Scoring System The range in scores is 0 to 19 with higher scores indicating worse neuropathy |
| Mean Score of National Cancer Institute - Common Toxicity Criteria | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | National Cancer Insitute - Common Toxicity Criteria The range in scores is 0 to 5, with higher scores indicating worse toxicity |
| Mean Score of Total Neuropathy Scores | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Total Neuropathy score The range in scores is 0 to 40, with higher scores indicating worse neuropathy |
| Mean Score of Survey of Autonomic Symptoms, Column B | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Survey of Autonomic Symptoms, questions in Column B The range in scores is 0 to 55 for women and 0 to 60 for men, with higher scores indicating more bothersome symptoms |
| Mean Score of McGill Pain Visual Analog Scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | McGill Visual Analog Scale for Pain The range in scores is 0 to 100, with 0 indicting No pain and 100 indicating Worst pain possible |
| Mean Scores of Short Form McGill Pain Questionnaire | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Short Form McGill Pain Questionnaire The range in scores is 0 to 15, with higher scores indicating worse pain |
| Mean Score of Survey of Autonomic Symptoms, Column A | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Survey of Autonomic Symptoms, questions in column A The range in scores is 0 to 11 for women and 0 to 12 for men, with higher scores indicating more symptoms |
| Serum NF-L Levels | 1 year | Changes in serum NFL levels over the course of chemotherapy will be monitored to determine if NFL can be used as a biomarker for axonal damage in patients who develop CIPN. NFL will be measured at baseline, before each round of chemotherapy and at the completion of chemotherapy. Changes in NFL will be compared between patients who develop CIPN and those that do not. |
| Neurologic Examination_ Strength_ Toe Fan | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction |
| Neurologic Examination_ Strength_ Toe Flex | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction |
| Neurologic Examination_ Strength_ Inv | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction |
| Neurologic Examination_ Strength_ Ev | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction |
| Neurologic Examination_ Strength_ ADF | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction |
| Neurologic Examination_ Vibration Sense_Toe | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. |
| Neurologic Examination_ Vibration Sense_MM | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. |
| Neurologic Examination_ Vibration Sense_Knee | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. |
| Neurologic Examination_ Vibration Sense_DIP2 | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. |
| Neurologic Examination_ Vibration Sense_DIP5 | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. |
| Neurologic Examination_ Deep Tendon Reflexes _ Biceps | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. |
| Neurologic Examination_ Deep Tendon Reflexes _ Triceps | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. |
| Neurologic Examination_ Deep Tendon Reflexes _ BR | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. |
| Neurologic Examination_ Deep Tendon Reflexes _ Patella | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. |
| Neurologic Examination_ Deep Tendon Reflexes _ Achilles | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. |
| Mean Nerve Conduction Metrics (Amplitude)_DORSAL SURAL | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
| Change in Nerve Conduction Metrics (Amplitude)_MED PLANTAR | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
| Change in Nerve Conduction_Motor_ (Amplitude)_Peron-TA | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
| Mean of the Difference in Nerve Conduction Amplitudes Between Pre-Mid and Pre-Post exposure_Dorsal Sural | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. The outcome measure is reporting the average of the differences in amplitudes Pre-Mid and Pre-Post exposure (for example, the change from Pre and Mid is calculated, and then the change across all participants is averaged). |
| Change in Nerve Conduction/Mixed Nerve Amplitudes _Medial Plantar | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
| Change in Nerve Conduction/Mixed Nerve Amplitudes _Sural | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
| Change in Nerve Conduction_Motor_ (Amplitude)_Peron-EDB | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
| Change in Nerve Conduction Metrics (Amplitude)_SURAL | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EPR Oximetry All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points (pre-exposure, during-exposure or CIPN incidence, and post exposure), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have up to five EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | EPR Oximetry | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Body Mass Index (BMI) | 30.5 kg/m2 STANDARD_DEVIATION 6.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 7 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 6 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Relative Change in % pO2
EPR Oximetry will measure tissue oxygen levels in the injected foot during 10 minutes of breathing room air, 10 minutes while breathing 100% oxygen, and 10 minutes of room air.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: 3 patients underwent testing. 1 patient did not undergo the 100% oxygen condition at the End of Chemo, so there is no data for Mid-Point or recovery for that patient. Data was not gathered for the remaining 4 participants.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Relative Change in % pO2 | End of Chemo | 25.3 change in % oxygenation |
| Relative % pO2 Change From Baseline While Breathing Room Air | Relative Change in % pO2 | Mid-Point | 12.3 change in % oxygenation |
| Relative % pO2 Change From Baseline While Breathing 100% Oxygen | Relative Change in % pO2 | End of Chemo | 9.5 change in % oxygenation |
| Relative % pO2 Change From Baseline While Breathing 100% Oxygen | Relative Change in % pO2 | Mid-Point | 19 change in % oxygenation |
| Relative % pO2 Change From Baseline While Breathing Room Air (Recovery) | Relative Change in % pO2 | End of Chemo | 42.5 change in % oxygenation |
| Relative % pO2 Change From Baseline While Breathing Room Air (Recovery) | Relative Change in % pO2 | Mid-Point | 24 change in % oxygenation |
Secondary
Change in Nerve Conduction Metrics (Amplitude)_MED PLANTAR
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction Metrics (Amplitude)_MED PLANTAR | Pre | 7.5 uV | Standard Deviation 7.2 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction Metrics (Amplitude)_MED PLANTAR | Mid | 6.4 uV | Standard Deviation 7.1 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction Metrics (Amplitude)_MED PLANTAR | Post | 5.7 uV | Standard Deviation 6.9 |
Secondary
Change in Nerve Conduction Metrics (Amplitude)_SURAL
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction Metrics (Amplitude)_SURAL | Pre | 21.9 uV | Standard Deviation 13.1 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction Metrics (Amplitude)_SURAL | Mid | 16.6 uV | Standard Deviation 7 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction Metrics (Amplitude)_SURAL | Post | 19.5 uV | Standard Deviation 13.4 |
Secondary
Change in Nerve Conduction/Mixed Nerve Amplitudes _Medial Plantar
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre-Mid- is prior to chemotherapy exposure Pre-Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction/Mixed Nerve Amplitudes _Medial Plantar | Pre-Mid-Mean | -1.0 uV |
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction/Mixed Nerve Amplitudes _Medial Plantar | Pre-Post-Mean | -1.7 uV |
Secondary
Change in Nerve Conduction/Mixed Nerve Amplitudes _Sural
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre-Mid- is prior to chemotherapy exposure Pre-Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction/Mixed Nerve Amplitudes _Sural | Pre-Mid-Mean | -5.2 uV |
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction/Mixed Nerve Amplitudes _Sural | Pre-Post-Mean | -2.3 uV |
Secondary
Change in Nerve Conduction_Motor_ (Amplitude)_Peron-EDB
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction_Motor_ (Amplitude)_Peron-EDB | Pre | 4.6 mV | Standard Deviation 1.1 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction_Motor_ (Amplitude)_Peron-EDB | Mid | 3.4 mV | Standard Deviation 1.9 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction_Motor_ (Amplitude)_Peron-EDB | Post | 3.4 mV | Standard Deviation 2.7 |
Secondary
Change in Nerve Conduction_Motor_ (Amplitude)_Peron-TA
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction_Motor_ (Amplitude)_Peron-TA | Pre | 5.2 mV | Standard Deviation 1.4 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction_Motor_ (Amplitude)_Peron-TA | Mid | 5.1 mV | Standard Deviation 1.3 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction_Motor_ (Amplitude)_Peron-TA | Post | 5.1 mV | Standard Deviation 1.9 |
Secondary
Change in Nerve Conduction_Motor_ (Amplitude)_Tibial-AH
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction_Motor_ (Amplitude)_Tibial-AH | Pre | 9.2 mV | Standard Deviation 3.9 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction_Motor_ (Amplitude)_Tibial-AH | Mid | 9.0 mV | Standard Deviation 5.7 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Change in Nerve Conduction_Motor_ (Amplitude)_Tibial-AH | Post | 10.1 mV | Standard Deviation 6.8 |
Secondary
Mean Nerve Conduction Metrics (Amplitude)_DORSAL SURAL
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Nerve Conduction Metrics (Amplitude)_DORSAL SURAL | Pre | 6.2 uV | Standard Deviation 8.8 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Nerve Conduction Metrics (Amplitude)_DORSAL SURAL | Mid | 6.3 uV | Standard Deviation 7.7 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Nerve Conduction Metrics (Amplitude)_DORSAL SURAL | Post | 3.5 uV | Standard Deviation 4.7 |
Secondary
Mean of the Difference in Nerve Conduction Amplitudes Between Pre-Mid and Pre-Post exposure_Dorsal Sural
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. The outcome measure is reporting the average of the differences in amplitudes Pre-Mid and Pre-Post exposure (for example, the change from Pre and Mid is calculated, and then the change across all participants is averaged).
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre-Mid- is prior to chemotherapy exposure Pre-Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean of the Difference in Nerve Conduction Amplitudes Between Pre-Mid and Pre-Post exposure_Dorsal Sural | Pre-Mid-Mean | -0.47 uV |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean of the Difference in Nerve Conduction Amplitudes Between Pre-Mid and Pre-Post exposure_Dorsal Sural | Pre-Post-Mean | -3.87 uV |
Secondary
Mean Score of McGill Pain Visual Analog Scale
McGill Visual Analog Scale for Pain The range in scores is 0 to 100, with 0 indicting No pain and 100 indicating Worst pain possible
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of McGill Pain Visual Analog Scale | Pre | 21.0 score on a scale | Standard Deviation 23.8 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of McGill Pain Visual Analog Scale | Mid | 27.9 score on a scale | Standard Deviation 25.5 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of McGill Pain Visual Analog Scale | Post | 27.3 score on a scale | Standard Deviation 30.9 |
Secondary
Mean Score of National Cancer Institute - Common Toxicity Criteria
National Cancer Insitute - Common Toxicity Criteria The range in scores is 0 to 5, with higher scores indicating worse toxicity
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of National Cancer Institute - Common Toxicity Criteria | Pre | 0.3 score on a scale | Standard Deviation 0.8 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of National Cancer Institute - Common Toxicity Criteria | Mid | 0.7 score on a scale | Standard Deviation 1 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of National Cancer Institute - Common Toxicity Criteria | Post | 1.4 score on a scale | Standard Deviation 0.8 |
Secondary
Mean Score of Neuro-Quality of Life - Lower Extremity Function (Mobility) Scale
Neuropathy-Specific Quality of Life scale measuring Lower Extremity Function (Mobility) The range in scores is 19 to 95, with a lower score indicating more difficulty with lower extremity function
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Neuro-Quality of Life - Lower Extremity Function (Mobility) Scale | Pre | 89.1 score on a scale | Standard Deviation 10.1 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Neuro-Quality of Life - Lower Extremity Function (Mobility) Scale | Mid | 90.6 score on a scale | Standard Deviation 7.1 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Neuro-Quality of Life - Lower Extremity Function (Mobility) Scale | Post | 91.4 score on a scale | Standard Deviation 5.9 |
Secondary
Mean Score of Neuro-Quality of Life - Positive Affect and Well-Being Scale
Neuropathy-Specific Quality of Life scale measuring Positive Affect and Well Being The range in score is 23 to 115, with a low score indicating a less positive affect and well-being
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Neuro-Quality of Life - Positive Affect and Well-Being Scale | Pre | 93.9 score on a scale | Standard Deviation 21.5 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Neuro-Quality of Life - Positive Affect and Well-Being Scale | Mid | 96.3 score on a scale | Standard Deviation 17.4 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Neuro-Quality of Life - Positive Affect and Well-Being Scale | Post | 100.6 score on a scale | Standard Deviation 17.1 |
Secondary
Mean Score of Neuro-Quality of Life - Satisfaction With Social Roles and Activities Scale
Neuropathy-Specific Quality of Life scale measuring Satisfaction with Social Roles and Activities The range in scores is 47 to 235, with a lower score indicating less satisfaction with social roles and activities
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Neuro-Quality of Life - Satisfaction With Social Roles and Activities Scale | Pre | 172.9 score on a scale | Standard Deviation 46.4 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Neuro-Quality of Life - Satisfaction With Social Roles and Activities Scale | Mid | 187.1 score on a scale | Standard Deviation 33.5 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Neuro-Quality of Life - Satisfaction With Social Roles and Activities Scale | Post | 187.6 score on a scale | Standard Deviation 50 |
Secondary
Mean Score of Neuro-Quality of Life - Upper Extremity Function (Fine Motor, Activities of Daily Living) Scale
Neuropathy-Specific Quality of Life scale measuring Upper Extremity Function (Fine Motor, Activities of Daily Living) The range in scores is 20 to 100, with a low score indicating more difficulty with upper extremity function
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Neuro-Quality of Life - Upper Extremity Function (Fine Motor, Activities of Daily Living) Scale | Post | 97.9 score on a scale | Standard Deviation 4.4 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Neuro-Quality of Life - Upper Extremity Function (Fine Motor, Activities of Daily Living) Scale | Pre | 97.0 score on a scale | Standard Deviation 5.5 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Neuro-Quality of Life - Upper Extremity Function (Fine Motor, Activities of Daily Living) Scale | Mid | 99.3 score on a scale | Standard Deviation 1.5 |
Secondary
Mean Score of Survey of Autonomic Symptoms, Column A
Survey of Autonomic Symptoms, questions in column A The range in scores is 0 to 11 for women and 0 to 12 for men, with higher scores indicating more symptoms
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Survey of Autonomic Symptoms, Column A | Post | 2.0 score on a scale | Standard Deviation 1.4 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Survey of Autonomic Symptoms, Column A | Mid | 2.3 score on a scale | Standard Deviation 0.8 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Survey of Autonomic Symptoms, Column A | Pre | 2.4 score on a scale | Standard Deviation 1.1 |
Secondary
Mean Score of Survey of Autonomic Symptoms, Column B
Survey of Autonomic Symptoms, questions in Column B The range in scores is 0 to 55 for women and 0 to 60 for men, with higher scores indicating more bothersome symptoms
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Survey of Autonomic Symptoms, Column B | Pre | 5.9 score on a scale | Standard Deviation 3.7 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Survey of Autonomic Symptoms, Column B | Mid | 6.9 score on a scale | Standard Deviation 4.9 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Survey of Autonomic Symptoms, Column B | Post | 5.2 score on a scale | Standard Deviation 3.9 |
Secondary
Mean Score of The Neuropathy Total Symptom Score-6 Questionnaire
Neuropathy Total Symptom Score questionnaire with 6 questions The range is scores is 0 to 22 with a higher score indicating worse symptoms
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of The Neuropathy Total Symptom Score-6 Questionnaire | Pre | 0.3 score on a scale | Standard Deviation 0.5 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of The Neuropathy Total Symptom Score-6 Questionnaire | Mid | 2.2 score on a scale | Standard Deviation 1.8 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of The Neuropathy Total Symptom Score-6 Questionnaire | Post | 3.1 score on a scale | Standard Deviation 3.1 |
Secondary
Mean Score of Toronto Clinical Neuropathy Scoring System
Toronto Clinical Neuropathy Scoring System The range in scores is 0 to 19 with higher scores indicating worse neuropathy
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Toronto Clinical Neuropathy Scoring System | Pre | 2.1 score on a scale | Standard Deviation 2 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Toronto Clinical Neuropathy Scoring System | Mid | 5.3 score on a scale | Standard Deviation 3.4 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Toronto Clinical Neuropathy Scoring System | Post | 5.0 score on a scale | Standard Deviation 3.7 |
Secondary
Mean Score of Total Neuropathy Scores
Total Neuropathy score The range in scores is 0 to 40, with higher scores indicating worse neuropathy
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Total Neuropathy Scores | Pre | 1.3 score on a scale | Standard Deviation 1.1 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Total Neuropathy Scores | Mid | 6.0 score on a scale | Standard Deviation 5 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Score of Total Neuropathy Scores | Post | 8.1 score on a scale | Standard Deviation 6.2 |
Secondary
Mean Scores of Short Form McGill Pain Questionnaire
Short Form McGill Pain Questionnaire The range in scores is 0 to 15, with higher scores indicating worse pain
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Scores of Short Form McGill Pain Questionnaire | Pre | 3.3 score on a scale | Standard Deviation 4 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Scores of Short Form McGill Pain Questionnaire | Mid | 2.4 score on a scale | Standard Deviation 2.1 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Mean Scores of Short Form McGill Pain Questionnaire | Post | 2.3 score on a scale | Standard Deviation 1.9 |
Secondary
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Dorsal Sural CV
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: For the dorsal sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Dorsal Sural CV | Pre-Mid | 1.8 m/s |
| Relative % pO2 Change From Baseline While Breathing Room Air | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Dorsal Sural CV | Pre-Post | -1.5 m/s |
Secondary
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Med Plantar CV
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: For the Med Plantar sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Med Plantar CV | Pre-Post | -3.5 m/s |
| Relative % pO2 Change From Baseline While Breathing Room Air | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Med Plantar CV | Pre-Mid | -1.2 m/s |
Secondary
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP AMP, EDB
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: For the dorsal sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP AMP, EDB | Pre-Mid | -1.1 m/s |
| Relative % pO2 Change From Baseline While Breathing Room Air | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP AMP, EDB | Pre-Post | -1.4 m/s |
Secondary
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP, AT
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: For the dorsal sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP, AT | Pre-Mid | 0 m/s |
| Relative % pO2 Change From Baseline While Breathing Room Air | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP, AT | Pre-Post | 0 m/s |
Secondary
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CV, Distal
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: For the Peroneal CV, distal sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CV, Distal | Pre-Mid | 1.6 m/s |
| Relative % pO2 Change From Baseline While Breathing Room Air | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CV, Distal | Pre-Post | -2.2 m/s |
Secondary
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Sural CV
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: For the Sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Sural CV | Pre-Mid | 2.7 m/s |
| Relative % pO2 Change From Baseline While Breathing Room Air | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Sural CV | Pre-Post | 0.3 m/s |
Secondary
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Tibial CMAP, AH
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Population: For the dorsal sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Tibial CMAP, AH | Pre-Mid | -0.2 m/s |
| Relative % pO2 Change From Baseline While Breathing Room Air | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Tibial CMAP, AH | Pre-Post | 0.9 m/s |
Secondary
Neurologic Examination_ Deep Tendon Reflexes _ Achilles
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ Achilles | Pre | 4.14 units on a scale | Standard Deviation 0.77 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ Achilles | Mid | 1.57 units on a scale | Standard Deviation 1.78 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ Achilles | Post | 1 units on a scale | Standard Deviation 1.35 |
Secondary
Neurologic Examination_ Deep Tendon Reflexes _ Biceps
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ Biceps | Pre | 4.42 Units on a scale | Standard Deviation 0.51 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ Biceps | Mid | 3.28 Units on a scale | Standard Deviation 1.89 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ Biceps | Post | 2.14 Units on a scale | Standard Deviation 1.61 |
Secondary
Neurologic Examination_ Deep Tendon Reflexes _ BR
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ BR | Pre | 4.21 Units on a scale | Standard Deviation 0.57 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ BR | Mid | 3.28 Units on a scale | Standard Deviation 1.54 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ BR | Post | 1.92 Units on a scale | Standard Deviation 1.32 |
Secondary
Neurologic Examination_ Deep Tendon Reflexes _ Patella
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ Patella | Pre | 4 units on a scale | Standard Deviation 0.67 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ Patella | Mid | 3.28 units on a scale | Standard Deviation 1.13 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ Patella | Post | 2.71 units on a scale | Standard Deviation 1.63 |
Secondary
Neurologic Examination_ Deep Tendon Reflexes _ Triceps
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ Triceps | Mid | 3.14 Units on a scale | Standard Deviation 1.74 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ Triceps | Post | 2.57 Units on a scale | Standard Deviation 1.78 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Deep Tendon Reflexes _ Triceps | Pre | 4.14 Units on a scale | Standard Deviation 1.02 |
Secondary
Neurologic Examination_ Strength_ ADF
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ ADF | Pre | 5 Units on a scale | Standard Deviation 0 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ ADF | Mid | 5 Units on a scale | Standard Deviation 0 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ ADF | Post | 5 Units on a scale | Standard Deviation 0 |
Secondary
Neurologic Examination_ Strength_ Ev
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ Ev | Post | 4.96 Units on a scale | Standard Deviation 0.09 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ Ev | Pre | 5 Units on a scale | Standard Deviation 0 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ Ev | Mid | 4.96 Units on a scale | Standard Deviation 0.09 |
Secondary
Neurologic Examination_ Strength_ Inv
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ Inv | Pre | 5 Units on a scale | Standard Deviation 0 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ Inv | Mid | 4.96 Units on a scale | Standard Deviation 0.09 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ Inv | Post | 4.96 Units on a scale | Standard Deviation 0.09 |
Secondary
Neurologic Examination_ Strength_ Toe Fan
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ Toe Fan | Pre | 5 Units on a scale | Standard Deviation 0 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ Toe Fan | Mid | 4.98 Units on a scale | Standard Deviation 0.06 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ Toe Fan | Post | 4.89 Units on a scale | Standard Deviation 0.27 |
Secondary
Neurologic Examination_ Strength_ Toe Flex
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ Toe Flex | Pre | 5 Units on a scale | Standard Deviation 0 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ Toe Flex | Mid | 4.98 Units on a scale | Standard Deviation 0.06 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Strength_ Toe Flex | Post | 4.89 Units on a scale | Standard Deviation 0.31 |
Secondary
Neurologic Examination_ Vibration Sense_DIP2
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_DIP2 | Pre | 7.82 Units on a scale | Standard Deviation 0.46 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_DIP2 | Mid | 7.78 Units on a scale | Standard Deviation 0.57 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_DIP2 | Post | 7.53 Units on a scale | Standard Deviation 0.66 |
Secondary
Neurologic Examination_ Vibration Sense_DIP5
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_DIP5 | Pre | 7.72 Units on a scale | Standard Deviation 0.61 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_DIP5 | Mid | 7.76 Units on a scale | Standard Deviation 0.57 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_DIP5 | Post | 7.60 Units on a scale | Standard Deviation 0.59 |
Secondary
Neurologic Examination_ Vibration Sense_Knee
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_Knee | Pre | 6.96 Units on a scale | Standard Deviation 0.86 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_Knee | Mid | 7 Units on a scale | Standard Deviation 0.98 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_Knee | Post | 6.10 Units on a scale | Standard Deviation 0.68 |
Secondary
Neurologic Examination_ Vibration Sense_MM
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_MM | Mid | 6.44 Units on a scale | Standard Deviation 1.01 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_MM | Post | 5.78 Units on a scale | Standard Deviation 1.2 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_MM | Pre | 6.73 Units on a scale | Standard Deviation 0.8 |
Secondary
Neurologic Examination_ Vibration Sense_Toe
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense.
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_Toe | Pre | 6.71 Units on a scale | Standard Deviation 0.82 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_Toe | Mid | 4.66 Units on a scale | Standard Deviation 3.1 |
| Relative % pO2 Change From Baseline While Breathing Room Air | Neurologic Examination_ Vibration Sense_Toe | Post | 4.53 Units on a scale | Standard Deviation 2.09 |
Secondary
Serum NF-L Levels
Changes in serum NFL levels over the course of chemotherapy will be monitored to determine if NFL can be used as a biomarker for axonal damage in patients who develop CIPN. NFL will be measured at baseline, before each round of chemotherapy and at the completion of chemotherapy. Changes in NFL will be compared between patients who develop CIPN and those that do not.
Time frame: 1 year
Population: Samples were never gathered due to no participants enrolled after protocol was amended to include the collection of serum NF-L.