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：
10193538
负责人：
Ting Bao
金额：
$ 72.98万
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：
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/10193538
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 Care Patient Outcomes Assessments Patients Pharmaceutical Preparations Pharmacology Phase Physical therapy Pilot Projects Placebos Prevention Quality of life Questionnaires Randomized Randomized Controlled Trials Recommendation Recovery Research Scientist Sensory Severities Symptoms Testing Toxic effect United States Yoga afferent nerve arm cancer therapy care providers chemotherapy disability duloxetine effective therapy experience fall risk flexibility functional outcomes global health improved improved functioning malignant breast neoplasm meetings minimally invasive multidisciplinary neurotoxic neurotoxicity pain reduction primary endpoint primary outcome secondary endpoint side effect standard of care treatment as usual trial comparing 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.

项目摘要化学疗法诱导的周围神经病（CIPN）是最有害，常见的之一许多化学疗法剂的痛苦和残疾的副作用，没有有效治疗它。我们的飞行员IIB二臂试验表明，瑜伽治疗与与通常的护理控制相比，CIPN疼痛减轻和跌倒风险减轻。我们的目标通过识别有效治疗来提高癌症患者的功能和生活质量减轻与化疗有关的毒性。拟议项目的目标是确定瑜伽在治疗CIPN疼痛和改善功能方面的功效，并改善感觉神经恢复并降低癌症生存的风险。严重的CIPN疼痛。我们将进行第三阶段，随机，教育和通常的关怀与268名参与者的对照试验：1）确定八周瑜伽的效率对中度至重度CIPN疼痛的癌症存活中CIPN症状的治疗； 2）评估瑜伽与教育控制和通常护理对提高灵活性和降低跌倒的风险； 3）评估瑜伽与教育控制和常规的影响照顾生活质量和感觉纤维功能。