Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy

NCT ID: NCT04403802

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-16
• Study Completion Date: 2024-05-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Voxx Human Performance Technology Socks

Intervention Type: 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.

Placebo Socks

Intervention Type: 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 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)

Group Type: EXPERIMENTAL

Voxx Human Performance Technology Socks

Intervention Type: 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.

Placebo Socks

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VoxxLife

UNKNOWN

Sponsor Role: collaborator

Arash Asher, MD

OTHER

Sponsor Role: lead

Responsible Party

Arash Asher, MD

Director, Cancer Rehabilitation & Survivorship

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

CS Cancer at the Hunt Cancer Center

Torrance, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IIT2019-08-ASHER-VOXXSOCK

Identifier Type: -

Identifier Source: org_study_id