NCT04403802已完成不适用
IIT2019-08-ASHER-VOXXSOCK Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy: A Double Blind, Randomized, Controlled Crossover Trial
Arash Asher, MD4 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年10月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Change in Subjective Measurement of Chemotherapy-induced Peripheral Neuropathy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cancer, stage 1-
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Subjective Measurement of Chemotherapy-induced Peripheral Neuropathy
时间窗: 6 weeks
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.
次要结局
- Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Timed Up and Go Test)(6 weeks)
- Change in Quality of Life Measurement(6 weeks)
- Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Modified Total Neuropathy Scale)(6 weeks)
- Change in Cancer-related Symptom Experience(6 weeks)
- Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Modified Total Neuropathy Scale)(6 weeks)
- Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Timed Up and Go Test)(6 weeks)
- Change in Quality of Life Measurement(6 weeks)
- Change in Cancer-related Symptom Experience(6 weeks)
- Feasibility of Voxx Socks Use(6 weeks)
研究者
Arash Asher, MD
Director, Cancer Rehabilitation & Survivorship
Cedars-Sinai Medical Center
研究点 (4)
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