NCT01506466已完成不适用
Weight Variation and Mechanisms Involved, During Chemotherapy in Breast Cancer Patients
Centre Jean Perrin2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2011年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change from baseline in body composition
研究概览
简要总结
Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. However, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied.
Thus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •menopausal women
- •breast cancer
- •patients requiring chemotherapy treatment
- •WHO performance status 0-2
排除标准
- •diabetics
- •patients with metastases
- •other cancer
结局指标
主要结局
Change from baseline in body composition
时间窗: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
次要结局
- Change from baseline in energy balance(within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.)
- Change from baseline in muscle strength(within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.)
- Change from baseline in biological factors (hormonal, inflammatory, lipid, growth factors)(within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.)
研究者
研究点 (2)
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