NCT02509871已完成不适用
Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer
Centre Jean Perrin2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2015年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Measure of body composition
研究概览
简要总结
This cross-sectional study of pathophysiology will bring additional informations on body composition of patients treated by adjuvant hormonal therapy for breast cancer. This is a complementary study of Metaca study (AU882).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •postmenopausal women
- •patients requiring hormonal treatment
- •WHO performance status 0-2
- •patients initially included in MetaCa (AU882) protocol
- •Affiliation to a social security scheme (or be the beneficiary of such a plan)
- •patients who signed the informed consent form
排除标准
- •patients witg relapse, with metastases or other cancer
- •concurrent treatment with a drug test, or participation in a clinical trial within < 30 days
- •patients carrying an electronic medical device (eg pacemaker)
- •patients who refused to sign the consent form
研究组 & 干预措施
Body composition measurement
Other
DXA, impedance
干预措施: Body composition measurement (Other)
结局指标
主要结局
Measure of body composition
时间窗: After more than a year of hormonal therapy
To obtain additional data to those of Metaca study (AU882) to assess changes in body composition (fat mass, lean body mass in Kg) in women with breast cancer and treated with adjuvant hormonal therapy following chemotherapy
次要结局
- Assessment of anxiety and depression scores measured by Questionnaire HAD(After more than a year of hormonal therapy)
- Evaluation of the distribution of abdominal fat by measuring the waist and hip circumference(After more than a year of hormonal therapy)
- Evaluation of quality of life measured by Questionnaire (QLQ-C30)(After more than a year of hormonal therapy)
- Evaluation of the time sitting measured by Questionnaire IPAQ(After more than a year of hormonal therapy)
- Evaluate the change in body composition longitudinally from the data of the study Metaca(Between after 1 and 6 months after chemotherapy and after more than a year of hormonal therapy)
研究者
研究点 (2)
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