Chemotherapy-induced Peripheral Neuropathy, Neuropathy, Neuropathy;Peripheral
Conditions
Keywords
Chemo-induced Peripheral Neuropathy, Voxx Socks, Voxx Human Performance Technology, Voxx HPT
Brief summary
This is a double blind, randomized, crossover pilot study of Voxx Human Performance Technology Socks versus placebo socks for the treatment of chemotherapy-induced peripheral neuropathy in patients with cancer. Patients will be randomized 1:1 to one of the following regimens: * Arm A: Continuous wear of Voxx Human Performance Technology Socks for 2 weeks, followed by continuous wear of placebo socks for 2 weeks (separated by a 2-week washout period) * Arm B: Continuous wear of placebo socks for 2 weeks, followed by continuous wear of Voxx Human Performance Technology Socks for 2 weeks (separated by a 2-week washout period) Patients will be evaluated at three time points using an objective neuropathy assessment as well as self-report questionnaires assessing chemotherapy-induced peripheral neuropathy, quality of life, and cancer-related symptoms.
Interventions
DEVICEVoxx Human Performance Technology Socks
Voxx Human Performance Technology Socks are commercially-available socks that are drug and electrical free. The Voxx Human Performance Technology proprietary pattern is woven into a sock that is made of 70% cotton, 25% polyester, 3% spandex, and 2% nylon. Prior to the 2-week treatment window, patients will be provided with 6 pairs of Voxx Human Performance Technology socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming.
DEVICEPlacebo Socks
Placebo socks are identical to the Voxx Human Performance Technology socks but do not include the Voxx Human Performance Technology pattern woven into the sock. Placebo socks are made of the same fabric as Voxx Human Performance Technology socks and are drug and electrical free. Prior to the 2-week treatment window, patients will be provided with 6 pairs of placebo socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming.
Sponsors
VoxxLife
Arash Asher, MD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with cancer, stage 1-4. * Completed taxane- or platinum-based chemotherapy, vinca alkaloids, or bortezomib at least three months (90 days) ago. Current use of anti-estrogen therapy, Herceptin, or PARP inhibitors is okay. * Clinical diagnosis of chemotherapy-induced peripheral neuropathy by clinician. This will be based on symptom history (paresthesias, dysesthesias, allodynia), loss of deep tendon reflexes, decreased vibratory sensation, or the presence of symmetrical stocking-glove numbness or paresthesias beginning after neurotoxic chemotherapy. * Self-reported average neuropathic pain score of at least 4 on a 10-point scale over the past 1 month. * Age ≥ 18 years * Concomitant use of analgesics is permitted if the dose has been stable for at least 2 weeks prior to study enrollment (no new analgesics have been added, discontinued, or changed in the 2 weeks prior to randomization). * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion criteria
* Syphilis, alcoholic neuropathy, diabetic neuropathy, neurological disorders, brain injury, or stroke, as assessed by the treating physician. * Neuropathy related to abnormal thyroid stimulating hormone or cobalamin levels as assessed by treating physician. * Current severe depression, suicidal ideation, bipolar disease, alcohol abuse, or major eating disorder, as assessed by the treating physician. * Currently participating in another chemotherapy-induced peripheral neuropathy-targeted program or trial. * Participated in a non-pharmacologic therapy specifically for the treatment of chemotherapy-induced peripheral neuropathy, including Scrambler Therapy, mindfulness meditation, or other mind-body activities within 14 days (2 weeks) prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Subjective Measurement of Chemotherapy-induced Peripheral Neuropathy | 6 weeks | Impact on chemotherapy-induced peripheral neuropathy will be subjectively measured by changes in scores on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale. The minimum value is 0 and maximum value is 44, and a lower score means a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Modified Total Neuropathy Scale) | 6 weeks | Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Total Neuropathy Scale clinical. The minimum value is 0 and maximum value is 28, and a lower score means a better outcome. |
| Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Timed Up and Go Test) | 6 weeks | Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Timed Up and Go test. |
| Change in Quality of Life Measurement | 6 weeks | Impact on quality of life will be measured by the changes in scores on the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29). PROMIS-29 is a collection of short form instruments which encompass PROMIS domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social and activities) in addition to a single item assessing pain intensity. The PROMIS 29 contains 4 items per domain plus one pain intensity item, totaling 29 items. Each domain is scored separately. For all domains (besides pain intensity) the raw score lies between 4 to 20. The PROMIS-29 uses a T-score metric to score its domains, with a mean of 50 and a standard deviation of 10, where higher scores indicate better health or less of the concept being measured. |
| Change in Cancer-related Symptom Experience | 6 weeks | Impact on cancer-related symptom experience will be measured by changes in scores on the Edmonton Symptom Assessment Scale. The minimum value is 0 and maximum value is 100, and a lower score means a better outcome. |
| Feasibility of Voxx Socks Use | 6 weeks | Feasibility will be measured by the number of hours the socks are worn, as recorded in the patient's daily sock diary. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Voxx Socks Followed by Placebo Socks Continuous wear of Voxx Human Performance Technology Socks for 2 weeks, followed by continuous wear of placebo socks for 2 weeks (separated by a 2-week washout period)
Voxx Human Performance Technology Socks: Voxx Human Performance Technology Socks are commercially-available socks that are drug and electrical free. The Voxx Human Performance Technology proprietary pattern is woven into a sock that is made of 70% cotton, 25% polyester, 3% spandex, and 2% nylon.
Prior to the 2-week treatment window, patients will be provided with 6 pairs of Voxx Human Performance Technology socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming.
Placebo Socks: Placebo socks are identical to the Voxx Human Performance Technology socks but do not include the Voxx Human Performance Technology pattern woven into the sock. Placebo socks are made of the same fabric as Voxx Human Performance Technology socks and are drug and electrical free.
Prior to the 2-week treatment window, patients will be provided with 6 pairs of placebo socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming. | 14 |
| Arm B: Placebo Socks Followed by Voxx Socks Continuous wear of placebo socks for 2 weeks, followed by continuous wear of Voxx Human Performance Technology Socks for 2 weeks (separated by a 2-week washout period)
Voxx Human Performance Technology Socks: Voxx Human Performance Technology Socks are commercially-available socks that are drug and electrical free. The Voxx Human Performance Technology proprietary pattern is woven into a sock that is made of 70% cotton, 25% polyester, 3% spandex, and 2% nylon.
Prior to the 2-week treatment window, patients will be provided with 6 pairs of Voxx Human Performance Technology socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming.
Placebo Socks: Placebo socks are identical to the Voxx Human Performance Technology socks but do not include the Voxx Human Performance Technology pattern woven into the sock. Placebo socks are made of the same fabric as Voxx Human Performance Technology socks and are drug and electrical free.
Prior to the 2-week treatment window, patients will be provided with 6 pairs of placebo socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming. | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Arm A: Voxx Socks Followed by Placebo Socks | Arm B: Placebo Socks Followed by Voxx Socks | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 6 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 8 Participants | 14 Participants |
| Age, Continuous | 58.28571 years STANDARD_DEVIATION 16.44304 | 59.85714 years STANDARD_DEVIATION 10.91123 | 59.071429 years STANDARD_DEVIATION 13.716518 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 10 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 8 Participants | 14 Participants |
| Region of Enrollment United States | 14 participants | 14 participants | 28 participants |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 3 / 28 | 1 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Change in Subjective Measurement of Chemotherapy-induced Peripheral Neuropathy
Impact on chemotherapy-induced peripheral neuropathy will be subjectively measured by changes in scores on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale. The minimum value is 0 and maximum value is 44, and a lower score means a better outcome.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voxx Human Performance Technology Socks | Change in Subjective Measurement of Chemotherapy-induced Peripheral Neuropathy | 27.32 score on a scale | Standard Deviation 8.03 |
| Placebo Socks | Change in Subjective Measurement of Chemotherapy-induced Peripheral Neuropathy | 27.94 score on a scale | Standard Deviation 8.72 |
Secondary
Change in Cancer-related Symptom Experience
Impact on cancer-related symptom experience will be measured by changes in scores on the Edmonton Symptom Assessment Scale. The minimum value is 0 and maximum value is 100, and a lower score means a better outcome.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voxx Human Performance Technology Socks | Change in Cancer-related Symptom Experience | 26.39 score on a scale | Standard Deviation 17.89 |
| Placebo Socks | Change in Cancer-related Symptom Experience | 27.61 score on a scale | Standard Deviation 18.1 |
Secondary
Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Modified Total Neuropathy Scale)
Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Total Neuropathy Scale clinical. The minimum value is 0 and maximum value is 28, and a lower score means a better outcome.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voxx Human Performance Technology Socks | Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Modified Total Neuropathy Scale) | 8.22 score on a scale | Standard Deviation 2.36 |
| Placebo Socks | Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Modified Total Neuropathy Scale) | 8.88 score on a scale | Standard Deviation 3.13 |
Secondary
Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Timed Up and Go Test)
Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Timed Up and Go test.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voxx Human Performance Technology Socks | Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Timed Up and Go Test) | 10.19 seconds | Standard Deviation 2.96 |
| Placebo Socks | Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Timed Up and Go Test) | 10.55 seconds | Standard Deviation 3.02 |
Secondary
Change in Quality of Life Measurement
Impact on quality of life will be measured by the changes in scores on the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29). PROMIS-29 is a collection of short form instruments which encompass PROMIS domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social and activities) in addition to a single item assessing pain intensity. The PROMIS 29 contains 4 items per domain plus one pain intensity item, totaling 29 items. Each domain is scored separately. For all domains (besides pain intensity) the raw score lies between 4 to 20. The PROMIS-29 uses a T-score metric to score its domains, with a mean of 50 and a standard deviation of 10, where higher scores indicate better health or less of the concept being measured.
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Voxx Human Performance Technology Socks | Change in Quality of Life Measurement | Depression | 50.04 score on a scale | Standard Deviation 9.29 |
| Voxx Human Performance Technology Socks | Change in Quality of Life Measurement | Sleep Disturbance | 57.03 score on a scale | Standard Deviation 2.57 |
| Voxx Human Performance Technology Socks | Change in Quality of Life Measurement | Anxiety | 52.86 score on a scale | Standard Deviation 9.36 |
| Voxx Human Performance Technology Socks | Change in Quality of Life Measurement | Pain Interference | 57.75 score on a scale | Standard Deviation 8.97 |
| Voxx Human Performance Technology Socks | Change in Quality of Life Measurement | Fatigue | 52.18 score on a scale | Standard Deviation 9.65 |
| Voxx Human Performance Technology Socks | Change in Quality of Life Measurement | Ability to participate in social and activities | 49.86 score on a scale | Standard Deviation 8.78 |
| Voxx Human Performance Technology Socks | Change in Quality of Life Measurement | Physical Function | 43.19 score on a scale | Standard Deviation 8.29 |
| Placebo Socks | Change in Quality of Life Measurement | Ability to participate in social and activities | 49.11 score on a scale | Standard Deviation 10.41 |
| Placebo Socks | Change in Quality of Life Measurement | Physical Function | 42.66 score on a scale | Standard Deviation 8.94 |
| Placebo Socks | Change in Quality of Life Measurement | Anxiety | 52.76 score on a scale | Standard Deviation 9.13 |
| Placebo Socks | Change in Quality of Life Measurement | Depression | 49.63 score on a scale | Standard Deviation 8.93 |
| Placebo Socks | Change in Quality of Life Measurement | Fatigue | 53.94 score on a scale | Standard Deviation 11.12 |
| Placebo Socks | Change in Quality of Life Measurement | Sleep Disturbance | 56.76 score on a scale | Standard Deviation 2.67 |
| Placebo Socks | Change in Quality of Life Measurement | Pain Interference | 58.2 score on a scale | Standard Deviation 8.69 |
Secondary
Feasibility of Voxx Socks Use
Feasibility will be measured by the number of hours the socks are worn, as recorded in the patient's daily sock diary.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Voxx Human Performance Technology Socks | Feasibility of Voxx Socks Use | 17.31615 hours/day | Standard Deviation 6.463149 |
| Placebo Socks | Feasibility of Voxx Socks Use | 16.65153 hours/day | Standard Deviation 6.011369 |