Clinical trial NCT04403802: Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy
Official title: IIT2019-08-ASHER-VOXXSOCK Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy: A Double Blind, Randomized, Controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathy;Peripheral
Chemotherapy-induced Peripheral Neuropathy
Neuropathy
Keywords: Chemo-induced Peripheral Neuropathy
Voxx Socks
Voxx Human Performance Technology
Voxx HPT
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: VoxxLife
First posted: 2020-05-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change in Subjective Measurement of Chemotherapy-induced Peripheral Neuropathy
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Modified Total Neuropathy Scale)
timeFrame: 6 weeks
measure: Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Timed Up and Go Test)
timeFrame: 6 weeks
measure: Change in Quality of Life Measurement
timeFrame: 6 weeks
measure: Change in Cancer-related Symptom Experience
timeFrame: 6 weeks
measure: Feasibility of Voxx Socks Use
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Torrance
country: United States
facility: CS Cancer at the Hunt Cancer Center
state: California
Study officials:
References: