MC15C1 Randomized Scrambler Therapy vs TENS for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of Participants Who Achieve at Least a 50% Reduction in Their Primary Problematic Symptom (Either Pain or Tingling) From Baseline on Day 14
研究概览
简要总结
This randomized clinical trial studies how well MC5-A scrambler therapy or transcutaneous electrical nerve stimulation (TENS) therapy work in treating patients with chemotherapy-induced peripheral neuropathy (a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body). MC5-A scrambler therapy is a type of treatment for nerve pain that uses electrodes placed on the skin, where electricity is carried from the electrodes through the skin and blocks the pain. TENS is a procedure in which mild electric currents are applied to some areas of the skin. It is not yet known whether TENS therapy is more effective than MC5-A scrambler therapy in treating chemotherapy-induced peripheral neuropathy.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the efficacy of scrambler therapy (MC5-A scrambler therapy) compared to TENS therapy for pain and/or tingling related to chemotherapy-induced peripheral neuropathy (CIPN).
II. Evaluate the tolerability of scrambler therapy and compare it to TENS therapy, in this population.
III. Evaluate whether scrambler therapy, compared to TENS therapy, can decrease the use of pain medication for CIPN.
IV. Explore whether messenger ribonucleic acid (mRNA) gene expression before and after scrambler therapy shows similar findings to what Starkweather et al observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Pain or symptoms of CIPN of >= 3 months duration, for which the patient wants intervention
- •Note: neurotoxic chemotherapy must have been completed >= 3 months prior to registration and there must be no further planned neurotoxic chemotherapy for > 5 months after registration
- •Patients have to relate that tingling or pain was at least a four out of ten problem =< 7 days prior to registration, on a 0-10 scale where zero was no problem and ten was the worst possible problem
- •Note: the patient is expected to have tingling or pain of at least 4/10 at the time of the first treatment
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1, or 2
- •Life expectancy >= 6 months
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Ability to provide informed written consent
- •Case review by the study chair, or designate, as a case where treatment should be tried
排除标准
- •Any of the following:
- •Pregnant women
- •Nursing women
- •Women of childbearing potential who are unwilling to employ adequate contraception
- •Existing operational implantable drug delivery systems, e.g. Medtronic Synchromed
- •Existing implantable medical electronic devices, life-supporting medical devices, and medical monitoring devices
- •Note: metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices
- •History of myocardial infarction or ischemic heart disease within the past six months
- •History of epilepsy, brain damage, use of anticonvulsants for seizure prevention, concurrently using ketamine, symptomatic brain metastases
- •Skin conditions such as open sores that would prevent proper application of the electrodes
- •Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
- •Currently receiving gabapentin or pregabalin and not willing to be weaned off of these medications prior to Scrambler therapy initiation
- •Note: it is OK to continue these medications in patients who are receiving TENS
- •History of peripheral neuropathy prior to receiving neurotoxic chemotherapy
- •Prior treatment with Scrambler therapy
结局指标
主要结局
Number of Participants Who Achieve at Least a 50% Reduction in Their Primary Problematic Symptom (Either Pain or Tingling) From Baseline on Day 14
时间窗: Baseline to Day 14
The number of participants who achieve at least a 50% reduction in their primary problematic symptom (either pain or tingling) from baseline on Day 14. The participant specified their primary problematic symptom (either pain or tingling) and primary problematic area (either upper or lower extremity) at registration; the respective items used to measure each symptom are considered for this outcome measure. Pain and tingling are measured using either item #6 (How much tingling have you had in your \[fingers or hands; toes or feet\] on average over the past 24 hours?) or item #9 (How much pain have you had in your \[fingers or hands; toes or feet\] on average over the past 24 hours?). Both items use the same scale: 0=None, 10=As bad as can be, with higher scores indicating worse outcome on either the Patient Questionnaire: Before Each Treatment for Upper Extremity Neuropathy or Patient Questionnaire: Before Each Treatment for Lower Extremity Neuropathy at baseline and Day 14.
次要结局
- Number of Participants Indicating Yes, No, or Unsure for Therapy Recommendation to Other Patients With Similar Problems on the Subjective Global Impression of Change Instrument(At 10 weeks)
- Change in Sensory, Motor, and Autonomic Neuropathy Subscale Scores From Baseline to Week 10(Up to 10 weeks)
- Number of Participants Using Acetaminophen as Pain Medication(Up to 10 weeks)