Chemotherapy-induced Neuropathy
Conditions
Keywords
acupressure, chemotherapy induced neuropathy, auricular acupressure
Brief summary
The proposed randomized control trial will evaluate auricular point acupressure (APA) on chemotherapy-induced neuropathy (CIN), rigorously considering point specificity and placebo effects by integrating self-report measures, psychophysical measures (QST), endogenous biomarkers (cytokines), and neuro-imaging to investigate APA's efficacy and underlying mechanism(s).
Detailed description
Chemotherapy-induced neuropathy (CIN)-pain, numbness, or tingling distributed in the hands and feet-produces persistent symptoms affecting sensation and balance in cancer survivors. Up to 50% of cancer survivors still suffer CIN 6 years after treatment. Duloxetine, the only recommended drug by the American Society of Clinical Oncology, was found to be superior to placebo but improved CIN by only 0.73 points (0-10 scale). No effective treatment for CIN has been established except exercise, with an effect size of \<0.508. Opioids relieve CIN pain, but long-term use is strongly discouraged due to opioid overuse. The investigators propose to test auricular point acupressure (APA), an innovative and scalable solution developed from auricular acupuncture. APA is a non-invasive (needleless) and active treatment for patients with pain, whereas acupuncture is an invasive (using needles) and passive treatment (administered by a licensed practitioner). In APA, small seeds are taped on specific ear points by a skilled provider and patients press on the seeds to stimulate ear points three times daily, three minutes per time, for a total of nine minutes per day. APA provides pain relief within 1-2 minutes after ear stimulation and sustains pain relief for one month after a 4-week APA intervention. APA is popular in Taiwan, China, and Europe. Though its use is sparse in the U.S., a limited number of clinical trials have supported APA in pain management.
Interventions
OTHERIn-person training for seed placement and APA
In-person seed placement and a training for the participant or their caregiver to place the seeds on the ear points.
OTHERVirtual training for seed placement and APA
Self-administer APA by placing the seeds according to the video instruction found in the self-guided smartphone application for understanding and administering APA. Participant and/or a caregiver will follow the video instruction on seed placement.
OTHERUsual Care
Participants will continue with usual care from oncologist.
OTHERPost-training zoom session for seed placement and APA coaching
Zoom session for seed placement and APA coaching, to occur after initial APA and seed placement training (initial training is either in person or guided by the smartphone app videos).
Sponsors
The University of Texas Health Science Center, Houston
National Cancer Institute (NCI)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Participants and interventionists cannot be masked to the three arms. The PI and Co-Is will be blinded regarding arm assignment and will not contact or interact with the participants during the intervention and outcome assessments. Data collector for outcome assessments will be blinded since there will be no seeds placed on the ears when the data are collected.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* cancer patients ages ≥18 years * have received a medication in one of the following categories: platinum-based, vinca alkaloids, bortezomib, eribulin, and/or taxanes * have CIN due to receiving neurotoxic chemotherapy for cancer or have pre-existing peripheral neuropathy of another etiology that worsened after chemotherapy * have one of the average intensity of pain, or numbness, or tingling on their extremities the previous week due to CIN ≥ 4 on a 11-point numerical scale.
Exclusion criteria
* use of an investigational agent for pain control concurrently or within the past 30 days * use of an implantable drug delivery system, e.g. Medtronic SynchroMed® * prior celiac plexus block or other neurolytic pain control treatment * other identified causes of painful paresthesia existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy,) * allergy to latex (the tapes for the APA include latex) and/or having a history of allergic reactions to the adhesive tape * pregnant women (based on the self-reported data) * individuals diagnosed with diabetic neuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity as Assessed by the Brief Pain Inventory | Baseline, 1 month after baseline | Brief Pain Inventory (BPI) assesses worst pain severity. The scale ranges from 0 (no pain) to 10 (severe pain), a higher score indicates greater pain |
| Numbness as Assessed by the Brief Pain Inventory | Baseline, 1 month after Baseline | Brief Pain Inventory (BPI) assesses worst numbness. The scale ranges from 0 (no numbness) to 10 (severe numbness), a higher score indicates greater numbness. |
| Tingling as Assessed by the Brief Pain Inventory | Baseline, 1 month after baseline | Brief Pain Inventory (BPI) assesses worst Tingling. The scale ranges from 0 (no tingling) to 10 (severe tingling), a higher score indicates greater tingling. |
| Stiffness as Assessed by the Brief Pain Inventory | Baseline, 1 month after baseline | Brief Pain Inventory (BPI) assesses worst stiffness. The scale ranges from 0 (no stiffness) to 10 (severe stiffness), a higher score indicates greater stiffness. |
| Grade of Peripheral Motor Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4 | Baseline, 1 month after baseline | Peripheral motor neuropathy is graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Severity is graded on a scale that ranges from 1 to 5, with higher grade indicating greater severity of neuropathy. |
| Grade of Peripheral Sensory Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4 | Baseline, 1 month after baseline | Peripheral sensory neuropathy is graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Severity is graded on a scale that ranges from 1 to 5, with higher grade indicating greater severity of neuropathy. |
| Physical Function as Assessed by The Revised BPI-CIN Pain Interference Subscale | Baseline, 1 month after Baseline | The BPI-CIN Interference subscale will be used to measure physical function caused by CIN. The seven items evaluate interference with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life. Each item is rated on a 0-10 numeric scale (0 = does not interfere; 10 = completely interferes). The overall score is calculated as the mean of the seven items with a total score ranging from 0 to 10 to determine the level of interference, with higher scores indicating greater interference. |
| Functional Ability as Assessed by Eastern Cooperative Oncology Group (ECOG) Performance Status Scale | Baseline, 1 month after Baseline | The ECOG Performance Status Scale describes level of functioning in terms of ability to care for oneself, daily activity, and physical. Score on the ECOG ranges from 0 (fully active and able) to 5 (dead) with higher score indicating lower function: 0 - Fully active, able to carry on all pre-disease performance without restriction 1. \- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. \- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. \- Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. \- Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. \- Dead |
| Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Physical Function Subscale | Baseline, 1 month after baseline | Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - physical function subscale assesses physical function using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty). Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80. The higher T-scores indicate better physical function. |
| Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Fatigue Subscale | Baseline, 1 month after baseline | Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - fatigue subscale assesses fatigue using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty). Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80. The higher T-scores indicate greater fatigue. |
| Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Pain Interference Subscale | Baseline, 1 month after baseline | Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - pain interference subscale assesses how pain interferes with daily activities using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty). Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80. The higher T-scores indicate greater pain interference. |
| Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Depression Subscale | Baseline, 1 month after baseline | Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - depression subscale assesses depression using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty). Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80. The higher T-scores indicate greater depression severity. |
| Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Anxiety Subscale | Baseline, 1 month after baseline | Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - anxiety subscale assesses anxiety using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty). Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80. The higher T-scores indicate greater anxiety. |
| Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Sleep Disturbance Subscale | Baseline, 1 month after baseline | Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - sleep disturbance subscale assesses sleep disturbance using 4 items, each scored on a 5-point Likert scale (1 = Unable to do; 5 = Without any difficulty). Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80. The higher T-scores indicate greater sleep disturbance. |
| Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Ability to Participate in Social Activities Subscale | Baseline, 1 month after baseline | Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - ability to participate in social activities subscale assesses a participant's perceived ability to engage in usual social roles and activities using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty). Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80. The higher T-scores indicate better and higher functioning social participation. |
| Upper Limb Function as Assessed by the Quick Dash Index | Baseline, 1 month after baseline | The QuickDASH Index assesses upper limb disability and symptoms. It evaluates limitations in daily activities (e.g., opening jars, performing housework), as well as pain, tingling, and sleep disturbances. The total score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating greater disability. |
| Symptoms Severity as Assessed by the MD Anderson Symptom Severity Inventory | Baseline, 1 month after Baseline | The MD Anderson Sympton Severity Inventory assesses severity of 13 common symptoms experienced by patients with cancer. Each item is rated on a 0-10 numeric scale (0 = not present; 10 = as bad as you can imagine). The overall symptom severity score is calculated as the mean of the 13 items with a range of 0 to 10, higher scores indicating greater symptom severity. |
| Pain Self Efficacy as Assessed by Pain Self-Efficacy Questionnaire (PSEQ) | Baseline, 1 month after Baseline | Pain self-efficacy is assessed using the Pain Self-Efficacy Questionnaire (PSEQ). This 10-item instrument measures a participant's confidence in performing daily activities, social life and function despite pain. Each item is rated on a 0-6 scale (0 = Not at all confident; 6 = Completely confident) and total score ranges from 0 to 60, with higher scores indicating greater self-efficacy and greater confidence in coping. |
| Psychological Impact of Pain as Assessed by the Pain Catastrophizing Score | Baseline, 1 month after Baseline | The Pain Catastrophizing Scale (PCS) assesses components of catastrophizing: rumination, magnification, and helplessness. The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing. |
| Number of Chronic Overlapping Pain Conditions as Assessed by the Chronic Overlapping Pain Conditions (COPC) | Baseline, 1 month after Baseline | Chronic Overlapping Pain Conditions (COPC) are assessed using the Chronic Overlapping Pain Conditions Screener (COPCS). This instrument identifies the presence of up to 10 common chronic pain conditions. The COPC total score is calculated as the number of positively identified conditions (answered "Yes"), with higher scores indicating greater pain impact, central sensitization, and severity. |
| Charlson Comorbidity Index | Baseline | The Charlson Comorbidity index assesses a participant's comorbidity burden and predicted risk of mortality. The total score ranges from 0 to 37. A higher score indicates greater comorbidity burden and higher risk of mortality. |
| Pain Impact as Assessed by Pain, Enjoyment and General Activity (PEG) Scale | Baseline, 1 month after baseline | Pain, Enjoyment and General Activity (PEG) is a three-item questionnaire that assesses pain intensity and its impact patient's daily life. Each item is rated on a 0-10 scale. The PEG score is calculated as the mean of three items, resulting in score range of 0 to 10, with a higher scores indicating greater pain severity and functional interference. |
| Number of Participants Reporting Opioid Use | Baseline, Day 28 | — |
| Opioid Use Per Day as Measured by the Morphine Milligram Equivalents (MME) Per Day | Baseline, Day 28 | Opioid use will be collected via EMA diary using a questionnaire. Milligram Morphine Equivalent (MME) will be determined by using an equivalency factor to calculate a dose of morphine equivalent to the ordered opioid. Daily morphine equivalent dosing is sum of the MME of all opioids a patient is likely to take within 24 hours, and will be calculated to MME for analysis. Baseline was defined as the first day of opioid use recorded in the EMA diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Trapezius | Baseline, 1 month after Baseline | In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM). To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm\^2) per second to the participant's trapezius and thumbs. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants indicated that the pressure sensation ''first becomes painful" is reported. |
| Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Thumb | Baseline, 1 month after Baseline | In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM). To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm\^2) per second to the participant's trapezius and thumbs. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants indicated that the pressure sensation ''first becomes painful" is reported. |
| Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Mechanical Temporal Summation (MTS) | Baseline, 1 month after Baseline | In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM). To assess MTS, a single pinprick stimulus (e.g., via a weighted pinprick stimulator or Neuropen) is applied, followed by a series of 10 rapid, identical stimuli at the same location, usually at a rate of 1/second, to measure the change in pain sensation. Participants rate their pain after the stimuli using a Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 = no pain and 10 = worst pain imaginable. A higher score means greater pain sensitivity and increased temporal summation. MTS is calculated as the increase in pain intensity rating (Δ change score) between the first stimulus and the end of the series. |
| Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM) | Baseline, 1 month after Baseline | In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM). CPM was assessed as the change in PPT on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold-water bath (Neslab, Portsmouth, NH) at 4 degrees Celsius for 20 seconds. \[ \[To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm\^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).\] |
| Functional Connectivity Changes in Salience Network - Basal Ganglia Network (SAL-BGN) as Assessed by fMRI Neuroimaging | Baseline | Functional Magnetic Resonance Imaging (fMRI) will be used to assess changes in functional connectivity between the Salience Network and Basal Ganglia Network (SAL-BGN) from baseline to post-intervention (1 month after baseline). Functional connectivity is calculated based on the correlations in Blood Oxygen Level Dependent (BOLD) signal fluctuations in different brain regions. Connectivity strength will be quantified using Fisher z-transformed correlation coefficients, with higher values indicating stronger functional connectivity. |
| Functional Connectivity Changes in Language Network - Basal Ganglia Network (LAN-BGN) as Assessed by fMRI Neuroimaging | Baseline, 1 month after Baseline | Functional Magnetic Resonance Imaging (fMRI) will be used to assess changes in functional connectivity between the Salience Network and Basal Ganglia Network (SAL-BGN) from baseline to post-intervention (1 month after baseline). Functional connectivity is calculated based on the correlations in Blood Oxygen Level Dependent (BOLD) signal fluctuations in different brain regions. Connectivity strength will be quantified using Fisher z-transformed correlation coefficients, with higher values indicating stronger functional connectivity. |
| The Grooved Pegboard Test-Dominant Hand | Baseline, 1 month after baseline | The Grooved Pegboard Test assesses fine motor skills, speed, and visual-motor coordination. Participants are asked to place 25 pegs into slots as quickly as possible. The total time to complete the task is recorded in seconds with dominant hand. Higher times indicate slower performance and reduced dexterity |
| The Grooved Pegboard Test-Non Dominant Hand | Baseline, 1 month after Baseline | The Grooved Pegboard Test assesses fine motor skills, speed, and visual-motor coordination. Participants are asked to place 25 pegs into slots as quickly as possible. The total time to complete the task is recorded in seconds with non-dominant hand. Higher times indicate slower performance and reduced dexterity |
| Interleukin-1 Alpha Level (From Plasma) | Baseline, 1 month after Baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Interleukin-1 Beta Level (From Plasma) | Baseline, 1 month after Baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Interleukin-2 Level (From Plasma) | Baseline, 1 month after Baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Interleukin-4 Level (From Plasma) | Baseline, 1 month after Baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Interleukin-6 Level (From Plasma) | Baseline, 1 month after Baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Interleukin-8 Level (From Plasma) | Baseline, 1 month after Baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Interleukin-10 Level (From Plasma) | Baseline, 1 month after Baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Interleukin-12 Level (p40) (From Plasma) | Baseline, 1 month after Baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Interleukin-12 Level (p70)-(From Plasma) | Baseline, 1 month after Baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Interleukin-13 Level (From Plasma) | Baseline, 1 month after Baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Interleukin-17 Level (From Plasma) | Baseline, 1 month after Baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Interferon-gamma Level (From Plasma) | Baseline, 1 month after Baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Tumor Necrosis Factor-alpha Level (From Plasma) | Baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Transforming Growth Factor-beta Level 1(From Plasma) | Baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Transforming Growth Factor-beta Level 1 (From Plasma) | 1 month after baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Calcitonin Gene-related Peptide Level(From Plasma) | Baseline, 1 month after baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Monocyte Chemoattractant Protein-1 Level (From Plasma) | Baseline, 1 month after baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| Eotaxin Level (From Plasma) | Baseline, 1 month after baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
| C-reactive Protein Level (From Plasma) | Baseline, 1 month after baseline | Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN
The University of Texas Health Science Center, Houston
PRINCIPAL_INVESTIGATORNada Lukkahatai, PHD, MSN, RN
Johns Hopkins University
Participant flow
Pre-assignment details
Of the 238 participants enrolled, 227 were randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.1 years STANDARD_DEVIATION 11.4 |
| Education College graduate | 73 Participants |
| Education High school, technical/vocational, or less | 17 Participants |
| Education Post-graduate degree | 78 Participants |
| Education Some college | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 142 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Martial Status Currently married or living with a partner | 51 Participants |
| Martial Status Never married | 4 Participants |
| Martial Status Separated, Divorced, Widowed | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 51 Participants |
| Region of Enrollment United States | 227 participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 33 Participants |
| Type of Cancer Breast | 50 Participants |
| Type of Cancer Dermatologic (Melanoma) | 0 Participants |
| Type of Cancer Gastrointestinal (colon/rectal, pancreatic, liver) | 73 Participants |
| Type of Cancer Genitourinary (prostate, bladder, kidney) | 18 Participants |
| Type of Cancer Gynecologic (endometrial, ovarian) | 9 Participants |
| Type of Cancer Hematologic (Leukemia, Lymphoma) | 7 Participants |
| Type of Cancer Not Applicable | 5 Participants |
| Type of Cancer Other | 55 Participants |
| Type of Cancer Thoracic (lung, thyroid) | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 80 | 1 / 75 | 3 / 72 |
| other Total, other adverse events | 5 / 80 | 5 / 75 | 6 / 72 |
| serious Total, serious adverse events | 0 / 80 | 0 / 75 | 0 / 72 |
Outcome results
None listed