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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04403802
Other study ID # IIT2019-08-ASHER-VOXXSOCK
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 16, 2020
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source Cedars-Sinai Medical Center
Contact Chris Waring
Phone 920-217-0317
Email Christopher.Waring@cshs.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Voxx Human Performance Technology Socks
Voxx Human Performance Technology Socks are commercially-available socks that are drug and electrical free. The Voxx Human Performance Technology proprietary pattern is woven into a sock that is made of 70% cotton, 25% polyester, 3% spandex, and 2% nylon. Prior to the 2-week treatment window, patients will be provided with 6 pairs of Voxx Human Performance Technology socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming.
Placebo Socks
Placebo socks are identical to the Voxx Human Performance Technology socks but do not include the Voxx Human Performance Technology pattern woven into the sock. Placebo socks are made of the same fabric as Voxx Human Performance Technology socks and are drug and electrical free. Prior to the 2-week treatment window, patients will be provided with 6 pairs of placebo socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming.

Locations

Country Name City State
United States Cedars Sinai Medical Center Los Angeles California
United States CS Cancer at the Hunt Cancer Center Torrance California

Sponsors (2)

Lead Sponsor Collaborator
Arash Asher, MD VoxxLife

Country where clinical trial is conducted

United States, 

Outcome

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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