Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy

Arash Asher, MD

Status: Completed

Conditions: Chemotherapy-induced Peripheral Neuropathy; Neuropathy;Peripheral; Neuropathy

Treatments: Device: Voxx Human Performance Technology Socks; Device: Placebo Socks

Study type: Interventional

Funder types: Other

Identifiers

NCT04403802

IIT2019-08-ASHER-VOXXSOCK

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

28 participants in 2 patient groups

Arm A: Voxx socks followed by placebo socks

Experimental group

Description:

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)

Treatment:

Device: Placebo Socks

Device: Voxx Human Performance Technology Socks

Arm B: Placebo socks followed by Voxx socks

Experimental group

Description:

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)

Treatment:

Device: Placebo Socks

Device: Voxx Human Performance Technology Socks