Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy

Last updated: July 16, 2024
Sponsor: Arash Asher, MD
Overall Status: Completed

Phase

N/A

Condition

Neuropathy

Neurologic Disorders

Treatment

Voxx Human Performance Technology Socks

Placebo Socks

Clinical Study ID

NCT04403802
IIT2019-08-ASHER-VOXXSOCK
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Diagnosed with cancer, stage 1-4.

  • Completed taxane- or platinum-based chemotherapy, vinca alkaloids, or bortezomib atleast 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. Thiswill be based on symptom history (paresthesias, dysesthesias, allodynia), loss ofdeep tendon reflexes, decreased vibratory sensation, or the presence of symmetricalstocking-glove numbness or paresthesias beginning after neurotoxic chemotherapy.

  • Self-reported average neuropathic pain score of at least 4 on a 10-point scale overthe 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 complywith the requirements of the study.

Exclusion

Exclusion Criteria:

  • Syphilis, alcoholic neuropathy, diabetic neuropathy, neurological disorders, braininjury, or stroke, as assessed by the treating physician.

  • Neuropathy related to abnormal thyroid stimulating hormone or cobalamin levels asassessed by treating physician.

  • Current severe depression, suicidal ideation, bipolar disease, alcohol abuse, ormajor eating disorder, as assessed by the treating physician.

  • Currently participating in another chemotherapy-induced peripheralneuropathy-targeted program or trial.

  • Participated in a non-pharmacologic therapy specifically for the treatment ofchemotherapy-induced peripheral neuropathy, including Scrambler Therapy, mindfulnessmeditation, or other mind-body activities within 14 days (2 weeks) prior torandomization.

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Voxx Human Performance Technology Socks
Phase:
Study Start date:
October 16, 2020
Estimated Completion Date:
May 23, 2024

Connect with a study center

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • CS Cancer at the Hunt Cancer Center

    Torrance, California 90505
    United States

    Site Not Available

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