Prospective Randomized Feasibility Study on the Self Application of Hydrotherapy to Treat Menopausal Symptoms Caused by Breast Cancer Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Menopausal complaints (MRS II)
研究概览
简要总结
Breast cancer survivors often suffer from climacteric symptoms caused by treatment or diagnosis of their disease.
Hormone replacement therapy is contraindicated and other pharmacological options may also include the risk of stimulating hormone receptors. Hydrotherapy following the guidelines of naturopathy by S. Kneipp is a non-pharmacological treatment option which may influence climacteric symptoms by affecting the regulation of body temperature. In this study, the regular self application of hydrotherapy after initial training by a professional will be evaluated for its efficacy, practicability, and compatibility.
详细描述
Patients should use 2-5 different treatment options per day and fulfill a diary for symptoms and adherence to self-treatment for 12 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer diagnosis
- •Menopausal complaints score > 14 (MRS II)
- •End of last chemotherapy or radiotherapy > 2 months
- •Expected stable disease for the next 6 months
排除标准
- •Regular intake of glucocorticoids
- •Regular practice of hydrotherapy before inclusion
- •Start or change of other treatments/changes of lifestyle in order to influence menopausal symptoms
- •Psychiatric disorders with possible influence on compliance and adherence to the protocol
- •Other severe or progressive diseases with influence on compliance and adherence to the protocol
- •Contraindications to hydrotherapy (severe heart failure, relevant dermatological diseases, Raynaud's Phenomenon [M. Raynaud], peripheral arterial occlusive disease Fontaine stage IIb [VK IIb] or more, acute thrombosis, or thrombophlebitis)
研究组 & 干预措施
immediate treatment group (SBG)
immediate start of hydrotherapy (self treatment) in immediate treatment group (SBG)
干预措施: hydrotherapy according to Kneipp rules (Other)
waiting group (WG)
start of hydrotherapy (self treatment) after waiting period of 12 weeks
结局指标
主要结局
Menopausal complaints (MRS II)
时间窗: 12 and 24 weeks
次要结局
- Cortisol profile (saliva)(12 and 24 weeks)
研究者
Cornelia von Hagens
Head Complementary & Integrative Medicine, Dep. 4.2
Heidelberg University