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临床试验/NCT01686737
NCT01686737撤回不适用

Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients

Universität Duisburg-Essen4 个研究点 分布在 1 个国家开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
4
主要终点
Fatigue

研究概览

简要总结

Breast cancer is the most frequent cancer in women and is associated with profound restrictions of health-related quality of life and psychosocial health. More than three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While exercise interventions can improve fatigue in breast cancer patients, many patients request complementary treatment approaches. Therefore, this study investigates the effects of yoga in women with breast cancer compared to aerobic exercise and usual care.

It is hypothesized that yoga is more effective than usual care and equally effective as aerobic exercise.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • non-metastatic invasive breast cancer
  • currently receiving adjuvant chemotherapy
  • moderate to severe chemotherapy-induced fatigue
  • physical and cognitive capacity to participate in yoga or walking

排除标准

  • diagnosed and pharmacologically treated psychiatric disorder except depressive adaptation disorder as a reaction to cancer diagnosis
  • ECOG status > 1
  • prior malignancy with a disease-free survival < 10 years except curatively treated basalioma of the skin and carcinoma in situ of the cervix
  • prior ductal carcinoma in situ (DCIS) ot the breast
  • pregnancy or breastfeeding
  • regular practice of yoga or walking during the past 12 months

结局指标

主要结局

Fatigue

时间窗: Week 12

Multidimensional Fatigue Inventory

次要结局

  • Fatigue(Week 36)
  • Health-related quality of life(Week 12, week 36)
  • Depression and anxiety(Week 12, week 36)
  • Sleep quality(Week 12, week 36)
  • Perceived Stress(Week 12, week 36)
  • Salivary Cortisol(Week 12, week 36)
  • Safety(Week 0-36)

研究者

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

Holger Cramer

Postdoctoral fellow

Universität Duisburg-Essen

研究点 (4)

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