NCT01387841已完成2 期
Comparison of Yoga Versus Relaxation on Chemotherapy Induced Nausea and Vomiting (CINV) Outcomes Following Chemotherapy
Bharath Charitable Cancer Hospital and Institute2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Effect of yoga on chemotherapy induced nausea and vomiting
研究概览
简要总结
- This randomized controlled three arm study compares the effects of a yoga intervention with jacobsons progressive muscle relaxation training and only standard of care in chemotherapy naive cancer patients.
- This study will also assess the neurophysiological correlates of nausea and vomiting and assess if effects of intervention on nausea and vomiting outcomes are mediated by changes in gastric motility (electrogastrogram) or stress arousal (cardiac autonomic function and sympathetic skin response) or self reported anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with gynecologic malignancies (breast, ovary) and Lymphomas.
- •Age between 30-70 years.
- •Chemotherapy naïve.
- •High school education.
排除标准
- •Those with brain metastases
- •Concurring medical condition likely to influence survival
- •Uncontrolled diabetes and hypertension
- •GI metastases, peritoneal fluid, uraemia
- •Neurological disorders such as Parkinson's disease, myotonic dystrophy etc.
- •GI obstruction and past H/o abdominal surgeries.
- •Cognitive impairments.
- •Regular participation in a behavioral intervention/yoga in the last six months
结局指标
主要结局
Effect of yoga on chemotherapy induced nausea and vomiting
时间窗: 4 months (prior to every cycle of chemotherapy,for 4 cycles)
This study is to evaluate the effects of yoga intervention vs. Jacobsons progressive muscle relaxation vs. standard of care only on chemotherapy induced nausea and emesis (CINV) outcomes
次要结局
- Quality of life after chemotherapy(4 months)
研究者
Dr Raghavendra Rao M
Senior Scientist and Head CAM pROGRAM
Bharath Charitable Cancer Hospital and Institute
研究点 (2)
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