Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy

IIT2019-08-ASHER-VOXXSOCK Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy: A Double Blind, Randomized, Controlled Crossover Trial

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.

Study Overview

• Status: Completed
• Conditions: Neuropathy; Chemotherapy-induced Peripheral Neuropathy; Neuropathy;Peripheral
• Intervention / Treatment: Device: Voxx Human Performance Technology Socks; Device: Placebo Socks

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Torrance, California, United States, 90505
      • CS Cancer at the Hunt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Device: 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.; 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.
Experimental: 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)	Device: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	6 weeks

Collaborators and Investigators

• Sponsor: Arash Asher, MD
• Collaborators: VoxxLife

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): May 23, 2024

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Chemo-induced Peripheral Neuropathy; Voxx Socks; Voxx Human Performance Technology; Voxx HPT
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuritis
• Other Study ID Numbers: IIT2019-08-ASHER-VOXXSOCK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No