Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- nausea and vomiting evaluation and quantification
研究概览
简要总结
This study aims to estimate the effect of the practice of a short-term partial fasting compared to a usual alimentation on nausea and vomiting within 5 days after the start of a chemotherapy session on 2 successive chemotherapy courses (4 sessions of chemotherapy) in patients starting treatment with highly emetogenic chemotherapy (ABVD or AVD protocol).
详细描述
Patients in fasting arm will practice partial fasting during 3 days (D-1, D1 (D day of chemotherapy) and D2) following a food guide during 4 chemotherapy sessions. Patients in usual alimentation arm will continue to take food as usual practice.
In each arm, patients will be interviewed at each chemotherapy sessions about nausea and vomiting (number and intensity of nausea and vomiting, treatments taken). Denutrition, quality of life improvement, compliance to partial fasting, treatment response will be evaluate too.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient starting a treatment by chemotherapy ABVD or AVD
- •patient affiliated to a social security scheme
- •patient who gives his informed consent before any procedure related to the study
排除标准
- •patient with diabetes
- •patient with recent gastric ulcer
- •patient with low BMI (less than 18,5 for patients under 70 or less than 21 for patient over 70)
- •albuminemia <35
- •patient wiht loss weight > 10% in 6 months
- •pregnant or lactating women
- •chronic alcoholism
- •unable to understand the objectives and risks of the study
- •patient with psychiatric desorder, under guardianship or under judicial protection
- •patient who cannot read
结局指标
主要结局
nausea and vomiting evaluation and quantification
时间窗: day 5 of the chemotherapy cycle
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
次要结局
未报告次要终点