Yoga for Chemotherapy-induced Peripheral Neuropathy Treatment (YCT) Trial

瑜伽治疗化疗引起的周围神经病变 (YCT) 试验

基本信息

批准号：
10911557
负责人：
Ting Bao
金额：
$ 30.75万
依托单位：
DANA-FARBER CANCER INST
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-01 至 2026-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10911557
关键词：
Adverse effects Affect American Society of Clinical Oncology Attention Brief Pain Inventory Cancer Center Cancer Patient Cancer Survivor Chemotherapy-induced peripheral neuropathy Clinical Clinical Trials Clinical Trials Design Complication Controlled Clinical Trials Data Education Equilibrium Fall prevention Fatigue Fiber Goals Gynecologic Oncology Group Headache Information Systems Intervention Longterm Follow-up Malignant Female Reproductive System Neoplasm Measurement Measures Methods Mind-Body Intervention Muscle National Cancer Institute Nausea Numbness Numeric Rating Scale Pain Participant Patient Outcomes Assessments Patients Pharmaceutical Preparations Phase Physical therapy Pilot Projects Placebos Prevention Quality of life Questionnaires Randomized Randomized, Controlled Trials Recommendation Recovery Research Risk Reduction Scientist Sensory Severities Symptoms Testing Treatment-related toxicity United States Yoga afferent nerve arm cancer therapy care providers chemotherapy disability duloxetine effective therapy efficacy evaluation experience fall risk flexibility functional improvement functional outcomes global health improved malignant breast neoplasm meetings minimally invasive multidisciplinary neurotoxic neurotoxicity pain reduction pharmacologic primary endpoint primary outcome secondary endpoint side effect standard of care treatment as usual trial comparing trial planning two-arm trial usual care arm

项目摘要

PROJECT SUMMARY Chemotherapy-induced Peripheral Neuropathy (CIPN) is one of the most harmful, common, painful, and disabling side effects of many chemotherapy agents and there is no effective treatment for it. Our pilot phase IIB two-arm trial showed that yoga treatment is associated with reduced CIPN pain and reduced risk of falls compared to 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 yoga in treating CIPN pain and improving function, as well as to improve sensory nerve recovery and reduce the risk of falls in cancer survivors suffering from moderate to severe CIPN pain. We will conduct a phase III, randomized, education and usual care- controlled trial with 268 participants to: 1) determine the efficacy of an eight-week yoga treatment on CIPN symptoms among cancer survivors with moderate to severe CIPN pain; 2) evaluate the effect of yoga versus education control and usual care on improving flexibility and reducing the risk of falls; and 3) evaluate the effect of yoga versus education control and usual care on quality of life and sensory fiber functioning.

项目概要化疗引起的周围神经病变 (CIPN) 是最有害、最常见的疾病之一许多化疗药物会产生痛苦和致残的副作用，但目前尚无有效的治疗方法我们的 IIB 期双臂试验表明，瑜伽治疗与此相关。与常规护理控制相比，减少 CIPN 疼痛并降低跌倒风险。通过确定有效的治疗方法来提高癌症患者的功能和生活质量拟议项目的目标是确定缓解化疗相关的毒性。瑜伽在治疗 CIPN 疼痛和改善功能以及改善感觉方面的功效神经恢复并降低中度至癌症幸存者跌倒的风险我们将进行 III 期随机、教育和常规护理- 268 名参与者参与的对照试验：1) 确定八周瑜伽的功效对患有中度至重度 CIPN 疼痛的癌症幸存者进行 CIPN 症状的治疗 2) 评估瑜伽与教育控制和常规护理在提高灵活性和灵活性方面的效果降低跌倒风险；3）评估瑜伽与教育控制和常规的效果关心生活质量和感觉纤维功能。