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：
10116658
负责人：
Ting Bao
金额：
$ 67.67万
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 2025-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10116658
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 Pharmacology Phase Pilot Projects Placebos Quality of life Randomized Randomized Controlled Trials Recommendation Recovery Research Role Sample Size Scientist Sensory Severities Solid Neoplasm Symptoms Tactile Techniques Testing Toxic effect United States afferent nerve arm base blind care providers chemotherapy chronic musculoskeletal pain conditioned pain modulation duloxetine effective therapy experience follow-up improved improved functioning minimally invasive multidisciplinary neurotoxic novel strategies outcome prediction overtreatment pain reduction painful neuropathy personalized chemotherapy placebo controlled study predicting response predictive test 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.

项目概要化疗最有害的副作用之一是化疗引起的外周血神经病 (CIPN)，是许多化疗药物常见的、痛苦的和致残的副作用对此没有有效的治疗方法。我们的 IIB 期三臂试验表明针灸治疗与 CIPN 疼痛减轻和触觉阈值改善相关与安慰剂和常规护理对照相比。我们的目标是增强癌症患者的功能和通过确定有效的治疗方法来减轻化疗相关的毒性，从而提高生活质量。这该项目的目标是确定针灸治疗 CIPN 疼痛的功效改善功能，以及改善癌症幸存者的感觉神经恢复患有中度至重度 CIPN 疼痛。我们将进行一项 III 期试验，有 250 名患者参与，随机、安慰剂（假针灸）对照试验，目的是：1) 确定治疗的疗效对中度至重度癌症幸存者的 CIPN 症状进行八周 EA 治疗 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 结果是否可以预测 EA 的反应。