Fasting Diet and Chemotherapy Toxicity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluation of the influence of short term fasting diet on the incidence of treatment-emergent adverse events [safety and tolerability]) caused by chemotherapy
研究概览
简要总结
This is a clinical trial aiming to assess the effect of fasting diet on chemotherapy - induced toxicities in breast cancer patients. The study will have an intevention group and a control group. The intervention group will follow a fasting diet of 60 hours (36h prior chemotherapy and 24h after the end of chemotherary), while the control group will follow regular (standard) diet. At the meantime of the chemotherapy cycles, the intervention group will be recommended to follow the Mediterranean diet.
The main questions this study is aiming to answer is whether short term fasting diet influences chemotherary - induced toxicities and if it is easy to be implemented.
详细描述
This is a clinical trial aiming to assess the effect of fasting diet on chemotherapy - induced toxicities in breast cancer patients. The study will have an intevention group and a control group. The intervention group will follow a fasting diet for 60 hours (36h prior chemotherapy and 24h after the end of chemotherapy), while the control group will follow regular diet. At the meantime of the chemotherapy cycles, the intervention group will be recommended to follow the Mediterranean diet. The patients will be randomized in the two groups. A total of 50 patients is required. Biochemical data, anthropometric measures and grading of toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events, nutritional habits, adherence to the Mediterranean diet (implementation of MedDietScore) will be assessed prior, during and after the intervention, in both groups. Nutritional counseling will be performed by Registered Dietitian, and telephone interviews will be used to record adherence to fasting diet and Mediterranean diet.
The main questions this study is aiming to answer is whether short term fasting diet influences chemotherary - induced toxicities and if it is easy to be implemented.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •breast cancer patients with first diagnosis of breast cancer
- •no distinct metastasis
- •patients will receive at least 4 cycles of adjuvant or neo-adjuvant chemotherapy
排除标准
- •BMI<19kg/m2
- •unintentional weight loss of >3 or >5 kg the last 3 or 6 months respectively
- •medical history of anorexia nervosa, boulimia or any other eating disorders
- •renal failure (creatinine >2mg/dl)
- •diabetes mellitus (type I or Insulin dependent type II)
- •serious psychiatric disease
- •serious cardiovascular disease
- •mobility limitations
- •being participant in any other study
结局指标
主要结局
Evaluation of the influence of short term fasting diet on the incidence of treatment-emergent adverse events [safety and tolerability]) caused by chemotherapy
时间窗: The patients with receive 4-8 cycles of chemotherapy,each cycle is repeated every 21 days. At the end of each cycle and prior next cycle the incidence of treatment - emergent adverse events (safety and tolerability) will be accessed.
Grade of toxicity will be accessed after each chempotherapy, using the National Cancer Institute Common Terminology Criteria for Adverse Events and eorct. Data will be collected and comparison between the two groups will be performed after each chemotherapy cycle.
次要结局
未报告次要终点
研究者
Odysseas Androutsos
Associate Professor of Clinical Nutrition and Dietetics
University of Thessaly