NCT00268125已完成3 期
Evaluation of Acupression's Bracelets Associated to an Educational Step Versus Education Only in Nausea and Vomiting's Mastering Induced by FEC100 Chemotherapy's Sort.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 3
- 主要终点
- Reduction of 15% of stage III/IV nausea and vomiting's incidence.
研究概览
简要总结
The purpose of this study is to demonstrate a betterment of the digestive symptomatology by the anti-emetic acupression's bracelets's use associated with hygiene and dietetic advices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age > 18 years
- •Well-informed written consent, signed by the patient before the beginning of the study
- •Breast cancer's diagnosis (operated or not)
- •Forecast of a treatment by FEC100 chemotherapy's sort (D1=D21) during at least 3 cycles.
- •Patient affiliated at a welfare or beneficiary from it
- •Investigator estimates that the patient is able to conform with protocol's conditions and to respect them
排除标准
- •Operated arm's lymphedema
- •Wrist's morphology which cannot permit the bracelet's wearing (20 cm)
- •D1=D15 FEC100's treatment
- •Psychic incapability to sign a well-informed consent
- •Refusal to give a written consent
- •Patient under tutelage or guardianship
- •Pregnant or breast-feeding woman
- •Any clinical trial's participation which would impose nausea and vomiting's treatment modalities
结局指标
主要结局
Reduction of 15% of stage III/IV nausea and vomiting's incidence.
次要结局
未报告次要终点
研究者
研究点 (3)
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