An interventional study of Voxx Human Performance Technology Socks and Placebo Socks in Neuropathy;Peripheral, Chemotherapy-induced Peripheral Neuropathy and Neuropathy, sponsored by Arash Asher, MD. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by Arash Asher, MD · Not applicable, Interventional, and Supportive care
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:
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.
73 studies on the registry are indexed under Neuritis; 20 are open to participants now.
This study's enrollment of 28 is below the median of 48 across 51 interventional studies indexed under Neuritis.
Browse Neuritis studies →Arash Asher, MD is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Device: Voxx Human Performance Technology Socks · Device: Placebo 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)
Device: Voxx Human Performance Technology Socks · Device: Placebo 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 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.
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
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
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
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
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
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
| Milestone | Arm A: Voxx Socks Followed by Placebo Socks | Arm B: Placebo Socks Followed by Voxx Socks |
|---|---|---|
| Started | 14 | 14 |
| Completed | 14 | 14 |
| Not completed | 0 | 0 |
| Milestone | Arm A: Voxx Socks Followed by Placebo Socks | Arm B: Placebo Socks Followed by Voxx Socks |
|---|---|---|
| Started | 14 | 14 |
| Completed | 14 | 14 |
| Not completed | 0 | 0 |
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.
| score on a scale | Voxx Human Performance Technology Socks | Placebo Socks |
|---|---|---|
| Change in Subjective Measurement of Chemotherapy-induced Peripheral Neuropathy | 27.32 ± 8.03 | 27.94 ± 8.72 |
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.
| score on a scale | Voxx Human Performance Technology Socks | Placebo Socks |
|---|---|---|
| Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Modified Total Neuropathy Scale) | 8.22 ± 2.36 | 8.88 ± 3.13 |
Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Timed Up and Go test.
| seconds | Voxx Human Performance Technology Socks | Placebo Socks |
|---|---|---|
| Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Timed Up and Go Test) | 10.19 ± 2.96 | 10.55 ± 3.02 |
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.
| score on a scale | Voxx Human Performance Technology Socks | Placebo Socks |
|---|---|---|
| Physical Function | 43.19 ± 8.29 | 42.66 ± 8.94 |
| Anxiety | 52.86 ± 9.36 | 52.76 ± 9.13 |
| Depression | 50.04 ± 9.29 | 49.63 ± 8.93 |
| Fatigue | 52.18 ± 9.65 | 53.94 ± 11.12 |
| Sleep Disturbance | 57.03 ± 2.57 | 56.76 ± 2.67 |
| Pain Interference | 57.75 ± 8.97 | 58.2 ± 8.69 |
| Ability to participate in social and activities | 49.86 ± 8.78 | 49.11 ± 10.41 |
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.
| score on a scale | Voxx Human Performance Technology Socks | Placebo Socks |
|---|---|---|
| Change in Cancer-related Symptom Experience | 26.39 ± 17.89 | 27.61 ± 18.1 |
Feasibility will be measured by the number of hours the socks are worn, as recorded in the patient's daily sock diary.
| hours/day | Voxx Human Performance Technology Socks | Placebo Socks |
|---|---|---|
| Feasibility of Voxx Socks Use | 17.31615 ± 6.463149 | 16.65153 ± 6.011369 |
Collected over from the start of treatment until 30 days following the end of treatment or until initiation of a new anticancer therapy (whichever occurs first). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Voxx Human Performance Technology Socks | 0/28 (0%) | 0/28 (0%) | 3/28 (10.7%) |
| Placebo Socks | 0/28 (0%) | 0/28 (0%) | 1/28 (3.6%) |
| Event | Voxx Human Performance Technology Socks | Placebo Socks |
|---|---|---|
| Pain in extremityMusculoskeletal and connective tissue disorders | 2/28 | 1/28 |
| Other - Skin IritationSkin and subcutaneous tissue disorders | 1/28 | 0/28 |
| Age, Categorical(Participants) | Arm A: Voxx Socks Followed by Placebo Socks | Arm B: Placebo Socks Followed by Voxx Socks | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 8 | 14 |
| >=65 years | 8 | 6 | 14 |
| Age, Continuous(years) | Arm A: Voxx Socks Followed by Placebo Socks | Arm B: Placebo Socks Followed by Voxx Socks | Total |
|---|---|---|---|
| Mean | 58.28571 ± 16.44304 | 59.85714 ± 10.91123 | 59.071429 ± 13.716518 |
| Sex: Female, Male(Participants) | Arm A: Voxx Socks Followed by Placebo Socks | Arm B: Placebo Socks Followed by Voxx Socks | Total |
|---|---|---|---|
| Female | 10 | 13 | 23 |
| Male | 4 | 1 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: Voxx Socks Followed by Placebo Socks | Arm B: Placebo Socks Followed by Voxx Socks | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 4 | 4 |
| Not Hispanic or Latino | 14 | 10 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm A: Voxx Socks Followed by Placebo Socks | Arm B: Placebo Socks Followed by Voxx Socks | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 3 | 7 |
| White | 6 | 8 | 14 |
| More than one race | 1 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm A: Voxx Socks Followed by Placebo Socks | Arm B: Placebo Socks Followed by Voxx Socks | Total |
|---|---|---|---|
| United States | 14 | 14 | 28 |
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Arash Asher, MD