Acupuncture for Chemothrapy-induced Peripheral Neuropathy Treatment (ACT)Trial

针灸治疗化疗引起的周围神经病变 (ACT) 试验

基本信息

批准号：
10532694
负责人：
Ting Bao
金额：
$ 64.17万
依托单位：
SLOAN-KETTERING INST CAN RESEARCH
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-12-01 至 2023-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10532694
关键词：
Acupuncture Therapy Affect American Society of Clinical Oncology Analgesics Brief Pain Inventory Cancer Center Cancer Patient Cancer Survivor Chemotherapy-induced peripheral neuropathy Chinese Traditional Medicine Clinical Clinical Trials Design Complication Data Double-Blind Method Effectiveness Electroacupuncture Fatigue Fiber Goals Headache Hour Impairment Intervention Longterm Follow-up Measurement Measures Methods Nausea Neurobiology Numbness Numeric Rating Scale Pain Pain Measurement Pain Threshold Participant Patient Care Patient Preferences Patients Peripheral Nervous System Diseases Pharmaceutical Preparations Phase Pilot Projects Placebos Prediction of Response to Therapy Quality of life Randomized Randomized, Controlled Trials Recommendation Recovery Research Role Sample Size Scientist Sensory Severities Solid Neoplasm Symptoms Tactile Techniques Testing Treatment-related toxicity United States afferent nerve arm blind care providers chemotherapy chronic musculoskeletal pain conditioned pain modulation duloxetine effective therapy efficacy evaluation experience follow-up functional improvement improved minimally invasive multidisciplinary neurotoxic novel strategies outcome prediction pain reduction painful neuropathy personalized chemotherapy pharmacologic placebo controlled study predicting response pressure primary outcome randomized placebo-controlled clinical trial side effect standard of care three-arm trial treatment as usual treatment effect treatment response vibration

项目摘要

Project Summary One of the most harmful side effects of chemotherapy is chemotherapy-induced peripheral neuropathy (CIPN), a common, painful, and disabling side effect of many chemotherapy agents for which there is no effective treatment. Our pilot phase IIB three-arm trial showed that acupuncture treatment is associated with reduced CIPN pain and improved tactile threshold compared to placebo and usual care control. We aim to increase cancer patients' function and quality of life by identifying effective treatments to alleviate chemotherapy-related toxicities. The goal of the proposed project is to determine the efficacy of acupuncture in treating CIPN pain and improving function, as well as to improve sensory nerve recovery in cancer survivors suffering from moderate to severe CIPN pain. We will conduct a phase III, 250-patient, randomized, placebo (sham acupuncture)-controlled trial to: 1) determine the efficacy of an eight-week EA treatment on CIPN symptoms among cancer survivors with moderate to severe CIPN pain; 2) evaluate the effect of EA vs. SA on small sensory fiber function; and 3) evaluate whether baseline QST outcomes predict response to EA.

项目摘要化学疗法最有害的副作用之一是化学疗法诱导的周围神经病（CIPN），这是许多化学疗法剂的常见，痛苦和残疾的副作用为此没有有效的治疗。我们的飞行员IIB三臂试验表明针灸治疗与CIPN疼痛减轻和触觉阈值有关与安慰剂和通常的护理控制相比。我们旨在提高癌症患者的功能和通过确定有效的治疗方法来减轻化学疗法相关的毒性，生活质量。这拟议项目的目标是确定针灸治疗CIPN疼痛的功效并改善功能，并改善癌症幸存者的感觉神经恢复患有中度到严重的CIPN疼痛。我们将进行III期，250名患者随机安慰剂（假针刺） - 对照试验至：1）确定八周的EA治疗中度至重度的癌症幸存者中的CIPN症状 CIPN疼痛； 2）评估EA与SA对小感觉纤维功能的影响； 3）评估基线QST结果是否预测对EA的反应。