Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy
NCT04403802 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2025-08-29
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
Interventions
- 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.
Sponsors & Collaborators
-
VoxxLife
collaborator UNKNOWN -
Arash Asher, MD
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-16
- Primary Completion
- 2024-05-22
- Completion
- 2024-05-23
- FDA Device
- Yes
Countries
- United States
Study Locations
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