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临床试验/NCT03292328
NCT03292328已完成不适用

Yoga for Chemotherapy-Induced Peripheral Neuropathy in Breast and GYN Cancer Survivors: A Pilot Study

Memorial Sloan Kettering Cancer Center3 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2017年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
3
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

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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