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

无线经皮电刺激（TENS）治疗化疗引起的周围神经病变：II 期随机临床试验

• 批准号: 10088114
• 负责人: Jennifer Gewandter
• 金额: $ 8.17万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-12 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10088114
• 关键词: Adherence; Analgesics; Animals; Area; Blinded; Burning Pain; Cancer Survivor; Chemotherapy-induced peripheral neuropathy; Chronic; Clinical Trials; Community Clinical Oncology Program; Confidence Intervals; Data; Devices; Dose; Double-Blind Method; Elements; Enrollment; Equilibrium; European Organization for Research and Treatment of Cancer; Fibromyalgia; Foundations; Hand; Home environment; Hour; Individual; Intervention; Leg; Link; Lower Extremity; Malignant Neoplasms; Measures; Methodology; Monitor; Muscle Cramp; Neurons; Neuropathy; Numbness; Numeric Rating Scale; Outcome Measure; Pain; Participant; Pathway interactions; Patient Outcomes Assessments; Patients; Peripheral Nervous System; Pharmacological Treatment; Phase; Physical activity; Physiological; Pilot Projects; Placebos; Polypharmacy; Program Efficiency; Quality of life; Randomized; Randomized Clinical Trials; Reporting; Research; Research Priority; Rest; Severities; Site; Sleep; Solid; Symptoms; Testing; Therapeutic; Transcutaneous Electric Nerve Stimulation; Treatment outcome; Walking; Wireless Technology; Work; actigraphy; arm; associated symptom; base; chemotherapeutic agent; chemotherapy; chronic painful condition; clinical practice; conditioned pain modulation; confirmatory trial; design; effective therapy; equilibration disorder; evidence base; falls; foot; health related quality of life; improved; meetings; neurotoxic; painful neuropathy; patient screening; phase III trial; primary outcome; programs; psychologic; public health relevance; reduce symptoms; side effect; treatment adherence; trial comparing; validation studies

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.

项目总结