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临床试验/NCT01908270
NCT01908270已完成不适用

Randomized Controlled Trial of Yoga for Menopausal Symptoms in Women With Breast Cancer

Universität Duisburg-Essen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Menopausal symptoms

研究概览

简要总结

Women with breast cancer and breast cancer survivors are often bothered by menopausal symptoms to a special degree. Treatment options for those symptoms are currently limited as hormone replacement therapy is often prohibited. Yoga has been shown to reduce menopausal symptoms as well as symptoms associated with breast cancer. Therefore, this study aims to investigate whether a 12-week yoga intervention can reduce menopausal symptoms in women with breast cancer and breast cancer survivors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Breast cancer (Stage I-III)
  • After completion of surgical therapy
  • After completion of adjuvant radiotherapy and chemotherapy
  • Score of 5 or greater on the Menopausal Rating Scale
  • Physical and cognitive capacity to participate in the yoga intervention
  • Willingness to participate in 10 or more of the 12 yoga interventions
  • signed informed consent

排除标准

  • Regular yoga practice in the past 12 months
  • Planned surgery in the study period
  • Diagnosed and medically treated psychosis
  • Hormone replacement therapy

结局指标

主要结局

Menopausal symptoms

时间窗: Week 12

Menopause Rating Scale

次要结局

  • Anxiety(Week 24)
  • Health-related quality of life (disease-specific)(Week 24)
  • Depression(Week 24)
  • Menopausal symptoms(Week 24)
  • Adverse events(Week 24)
  • Fatigue(Week 24)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Holger Cramer

Research Fellow

Universität Duisburg-Essen

研究点 (2)

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