Status:
COMPLETED
Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy
Lead Sponsor:
Arash Asher, MD
Collaborating Sponsors:
VoxxLife
Conditions:
Neuropathy;Peripheral
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04403802
Start Date
October 16 2020
End Date
May 23 2024
Last Update
August 29 2025
Active Locations (2)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
2
CS Cancer at the Hunt Cancer Center
Torrance, California, United States, 90505