Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy

NCT04403802 | Completed Results DMC FDA Device

• 1 other identifier: IIT2019-08-ASHER-VOXXSOCK
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Neuropathy;Peripheral; Chemotherapy-induced Peripheral Neuropathy; Neuropathy

Keywords

Chemo-induced Peripheral Neuropathy; Voxx Socks; Voxx Human Performance Technology; Voxx HPT

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (5)

• Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Modified Total Neuropathy Scale)

  6 weeks

• Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Timed Up and Go Test)

  6 weeks

• Change in Quality of Life Measurement

  6 weeks

• Change in Cancer-related Symptom Experience

  6 weeks

• Feasibility of Voxx Socks Use

  6 weeks

Study Arms (2)

Arm A: Voxx socks followed by placebo socks

EXPERIMENTAL

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

Arm B: Placebo socks followed by Voxx socks

EXPERIMENTAL

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

Interventions

Voxx Human Performance Technology Socks DEVICE

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.

Arm A: Voxx socks followed by placebo socks; Arm B: Placebo socks followed by Voxx socks

Placebo Socks DEVICE

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.

Arm A: Voxx socks followed by placebo socks; Arm B: Placebo socks followed by Voxx socks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arash Asher, MD: lead
• VoxxLife: collaborator

Study Sites (2)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

CS Cancer at the Hunt Cancer Center

Torrance, California, 90505, United States

Location

MeSH Terms

Conditions

Neuritis

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Arash Asher
• Organization: Cedars-Sinai Medical Center

arash.asher@cshs.org

310-423-1218

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Cancer Rehabilitation & Survivorship

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 27, 2020
• Study Start: October 16, 2020
• Primary Completion: May 22, 2024
• Study Completion: May 23, 2024
• Last Updated: August 29, 2025
• Results First Posted: May 7, 2025

Record last verified: 2025-08

Locations

US (2)