N/A N=28 Randomized Triple-blind Supportive Care

Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy

Neuropathy;Peripheral · Chemotherapy-induced Peripheral Neuropathy · Neuropathy

Bottom Line

View on ClinicalTrials.gov: NCT04403802 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2025

Primary outcome: Primary: Change in Subjective Measurement of Chemotherapy-induced Peripheral Neuropathy — 27.32; 27.94 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Voxx Human Performance Technology Socks (Device); Placebo Socks (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Arash Asher, MD
Primary completion: May 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Subjective Measurement of Chemotherapy-induced Peripheral Neuropathy	27.32; 27.94	—
SECONDARY Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Modified Total Neuropathy Scale)	8.22; 8.88	—
SECONDARY Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Timed Up and Go Test)	10.19; 10.55	—
SECONDARY Change in Quality of Life Measurement	43.19; 42.66; 52.86; 52.76; 50.04; 49.63	—
SECONDARY Change in Cancer-related Symptom Experience	26.39; 27.61	—
SECONDARY Feasibility of Voxx Socks Use	17.31615; 16.65153	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04403802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.