Chemotherapy-induced Peripheral Neuropathy Clinical Trial
Official title:
IIT2019-08-ASHER-VOXXSOCK Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy: A Double Blind, Randomized, Controlled Crossover Trial
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cedars Sinai Medical Center | Los Angeles | California |
United States | CS Cancer at the Hunt Cancer Center | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Arash Asher, MD | VoxxLife |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in subjective measurement of chemotherapy-induced peripheral neuropathy | 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. | 6 weeks | |
Secondary | Change in objective measurement of chemotherapy-induced peripheral neuropathy (score on the Modified Total Neuropathy Scale) | 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 24, and a lower score means a better outcome. | 6 weeks | |
Secondary | Change in objective measurement of chemotherapy-induced peripheral neuropathy (score on the Timed Up and Go test) | Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Timed Up and Go test. | 6 weeks | |
Secondary | Change in quality of life measurement | Impact on quality of life will be measured by the changes in scores on the Patient-Reported Outcomes Measurement Information System 29. The minimum value is 50 and maximum value is 110, and a lower score means a better outcome. | 6 weeks | |
Secondary | Change in cancer-related symptom experience | 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. | 6 weeks | |
Secondary | Feasibility of Voxx Socks use | Feasibility will be measured by the number of hours the socks are worn, as recorded in the patient's daily sock diary. | 6 weeks |
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