Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy- A Pragmatic Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
研究概览
简要总结
The aim of this trial is to investigate the effectiveness of acupuncture on quality of life in patients with breast cancer receiving chemotherapy compared to routine care.
详细描述
At the Mammazentrum Hamburg, Germany, patients with breast cancer receiving chemotherapy have the opportunity to get acupuncture in addition to conventional therapy to maintain quality of life and to reduce the side effects of the chemotherapy such as gastrointestinal disorders. In this randomized trial we aim to investigate the effectiveness of additional acupuncture compared to routine care in patients with breast cancer.
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
- •diagnosed breast cancer (invasive, intraductal, hormone-sensitive and not hormone-sensitive, only locoregional metastases)
- •current chemotherapy at Mammazentrum Hamburg with regimen FEC/DOC or EC/DOC
- •willingness to receive acupuncture within the next 6 month if randomized in acupuncture group
- •willingness to refrain from acupuncture within the next 6 month if randomized in control group
- •informed consent
排除标准
- •distant metastases
- •blood coagulation disorder and/or current use of anticoagulants
- •serious acute or chronic mental or physical disorders
- •clinically relevant cardiac arrhythmia symptoms
- •insufficient German language ability
研究组 & 干预措施
Usual care + acupuncture
干预措施: Usual care + acupuncture (Other)
Usual care
干预措施: Usual care (Other)
结局指标
主要结局
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
时间窗: 6 month
次要结局
- Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)(3 month)
研究者
Claudia M. Witt
Professor, MD
Charite University, Berlin, Germany