Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy

Not Applicable

Completed

Conditions: Neuropathy
Neuropathy;Peripheral
Chemotherapy-induced Peripheral Neuropathy

Registration Number: NCT04403802

Lead Sponsor: Arash Asher, MD

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 28

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Subjective Measurement of Chemotherapy-induced Peripheral Neuropathy	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Modified Total Neuropathy Scale)	6 weeks	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.
Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Timed Up and Go Test)	6 weeks	Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Timed Up and Go test.
Change in Quality of Life Measurement	6 weeks	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.
Change in Cancer-related Symptom Experience	6 weeks	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.
Feasibility of Voxx Socks Use	6 weeks	Feasibility will be measured by the number of hours the socks are worn, as recorded in the patient's daily sock diary.

Trial Locations

Locations (2): Cedars Sinai Medical Center
🇺🇸
Los Angeles, California, United States
CS Cancer at the Hunt Cancer Center
🇺🇸
Torrance, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States