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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
28
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 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.
Cedars Sinai Medical Center
Los Angeles, California, United States
CS Cancer at the Hunt Cancer Center
Torrance, California, United States
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.
Time frame: 6 weeks
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 28, and a lower score means a better outcome.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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 (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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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