Yoga for Chemotherapy-Induced Peripheral Neuropathy in Breast and GYN Cancer Survivors: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Change in treatment related peripheral neuropathy symptoms
研究概览
简要总结
Some types of chemotherapy used to treat breast cancer can cause damage to nerves with symptoms like tingling, numbness, muscle weakness, and pain in the hands and feet that can last and can affect functioning. The purpose of this study is to find out the effects of yoga on reducing symptoms caused by such nerve damage.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking
- •Age >/= 18 years old
- •Survivors with a primary diagnosis of stage I-III breast, ovarian uterine, or endometrial cancer
- •Moderate to severe chemotherapy induced peripheral neuropathy, defined by symptoms such as numbness, tingling, or pain ratings of 4 or greater on a 0-10 numeric rating scale
- •Have completed neurotoxic chemotherapy, i.e. taxanes (paclitaxel, docetaxel) and platinum (carboplatin) at least 3 months prior to enrollment
- •If taking anti-neuropathy medications, they are on a stable regiment (no change in 3 months)
- •ECOG performance status 0-2
排除标准
- •Participants with metastatic disease
- •Participants who are currently receiving physical therapy or practicing yoga for any reason
- •Control Group - Inclusion/Exclusion Criteria
- •Inclusion Criteria:
- •English speaking
- •Age >/= 18 years old
- •Survivors with a primary diagnosis of Stage I-III breast, ovarian, uterine, or endometrial cancer
- •CIPN symptoms such as numbness, tingling, or pain ratings < 2 on a 0-10 NRS scale
- •Have completed neurotoxic chemotherapy, i.e. taxanes (paclitaxel, docetaxel) and platinum (carboplatin) at least 3 months prior to enrollment
- •ECOG performance status 0-2
- •Exclusion Criteria:
- •Patients with metastatic disease
- •Patients taking anti-neuropathy medication
- •Patients who are currently receiving physical therapy or practicing yoga for any reason
研究组 & 干预措施
Yoga Arm
After randomization, participants in the Yoga group will meet twice weekly for 8 weeks of classes taught by MSK yoga instructors. Each class will last for sixty minutes. In addition to these group classes, participants will utilize a home-based program on the days group classes are not held. The daily home practice will continue for four weeks after the group classes are finished.
干预措施: Yoga (Other)
Wait List Control Arm (WLC)
Participants in the WLC group will continue usual care for twelve weeks before participating in Yoga classes for eight weeks. At the end of the twelve week follow-up, these participants will receive eight weeks of group Yoga classes and the home Yoga practice recording. At week 20, they will complete a final follow-up visit.
干预措施: Wait List Control (Other)
结局指标
主要结局
Change in treatment related peripheral neuropathy symptoms
时间窗: 8 weeks of the participants' most bothersome peripheral neuropathy symptom
Treatment related symptoms will be evaluated by using NCI CTCAE v4.0
次要结局
未报告次要终点