Wireless transcutaneous electrical stimulation (TENS) for chemotherapy-induced peripheral neuropathy: A phase II randomized clinical trial

项目摘要 化疗诱导的周围神经病变（CIPN）发生在约60%的患者中， 接受神经毒性化疗药物。CIPN的症状包括烧灼痛/刺痛，刺痛， 抽筋，手脚麻木CIPN与平衡、行走、 睡眠、生活质量下降和福尔斯。很少，只有最低限度有效的治疗方法可用于 CIPN;这些药物治疗很少以证据为基础，可能成瘾， 有助于多药治疗。有研究表明，CIPN是由异常的神经元 中枢和外周神经系统的处理，包括中枢降神经系统的减少 抑制机制数据表明，经皮电神经刺激（TENS）缓解 其他神经性疼痛症状，部分通过激活中枢下行抑制 途径，但这一机制尚未被调查的TENS在CIPN。拟议研究 目的是探讨TENS的初步疗效，TENS是一种安全，廉价，非药物治疗 对于CIPN。一项严格的II期、多中心、患者和评估者设盲的随机临床试验（RCT） 研究生理和心理机制，并利用NCI社区 肿瘤学研究计划（NCORP）的效率。研究的目的是为了获得 为开展确证性III期RCT提供信息。建议的TENS设备是一个病人- 一个可控制的无线单元，可以在身体活动期间方便地全天佩戴; 单位是理想的最大限度地坚持在临床试验和优化传播在临床 实践本研究的主要目的是获得初步疗效估计（效应量和 置信区间）的TENS对CIPN（CIPN 20）的复合测量。次要目标包括 获得（1）个体CIPN症状的初步功效估计（0 - 10数字评级 量表），（2）TENS对CIPN患者活动和平衡的初步疗效，（3） TENS对CIPN患者中枢下行抑制机制的影响，以及（4）TENS的可行性数据 在多中心NCORP研究网络中进行TENS的患者和评估者盲法RCT。 这项II期随机对照试验是一项研究计划的一个组成部分，该计划将严格评估 CIPN的TENS。为CIPN建立有效的非药物治疗将有助于减轻 癌症幸存者的痛苦，同时避免目前许多癌症患者可能造成的有害副作用。 可用的止痛药。

PROJECT SUMMARY Chemotherapy-induced peripheral neuropathy (CIPN) occurs in approximately 60% of patients who receive neurotoxic chemotherapy agents. Symptoms of CIPN include burning/shooting pain, tingling, cramping, and numbness in the hands and feet. CIPN is associated with impaired balance, walking, and sleep, decreased quality of life, and falls. Few, only minimally effective treatments are available for CIPN; these pharmacologic treatments are rarely evidenced-based, potentially addictive, and contribute to polypharmacy. Some research suggests that CIPN results from abnormal neuronal processing in the central and peripheral nervous systems, including decreased central descending inhibitory mechanisms. Data suggests that transcutaneous electrical nerve stimulation (TENS) relieves symptoms in other neuropathic pain conditions, partly by activating central descending inhibitory pathways, but this mechanism has yet to be investigated for TENS in CIPN. The proposed research aims to investigate the preliminary efficacy of TENS, a safe, inexpensive, non-pharmacologic treatment for CIPN. A rigorous phase II, multi-site, patient- and assessor-blinded randomized clinical trial (RCT) that investigates physiologic and psychologic mechanisms and leverages the NCI Community Oncology Research Program (NCORP) for efficiency is proposed. The purpose of the study is to obtain data to inform the conduct of a confirmatory, phase III RCT. The proposed TENS device is a patient- controlled, wireless unit that can conveniently be worn throughout the day during physical activity; the unit is ideal for maximizing adherence in clinical trials and for optimizing dissemination in clinical practice. The primary aim of the study is to obtain preliminary efficacy estimates (effect sizes and confidence intervals) of TENS on a composite measure of CIPN (CIPN20). Secondary aims include obtaining (1) preliminary efficacy estimates for individual CIPN symptoms (0 – 10 numeric rating scales), (2) preliminary efficacy of TENS on activity and balance in patients with CIPN, (3) effects of TENS on central descending inhibitory mechanisms in CIPN patients, and (4) feasibility data for conducting a patient- and assessor-blinded RCT of TENS in the multi-site NCORP Research Network. This phase II RCT is an integral step in a program of research that will rigorously evaluate the efficacy of TENS for CIPN. Establishing effective, non-pharmacologic treatments for CIPN will help to mitigate suffering in cancer survivors while avoiding potentially harmful side effects caused by many currently available analgesic drugs.