Diet And Nutrition In CAncer (The DANICA Study): The Effect of a Mediterranean Diet Intervention on Cancer-related Fatigue and Mitochondrial Function During Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- The Number of Patients Who Enrolled Completed the Study.
研究概览
简要总结
This study will assess the feasibility of delivering an 8-week Mediterranean Diet intervention as well as the intervention's preliminary efficacy on cancer-related fatigue among patients undergoing chemotherapy, compared to usual care. In the first 4 weeks of the intervention, we will provide the participants with food and educate them on the principles and components of the Mediterranean Diet, while in the second 4 weeks participants will prepare their own food. In addition, we will evaluate changes in metabolism and mitochondrial function during 4 weeks of chemotherapy and determine how adherence to a Mediterranean diet modulates these changes during these 4 weeks.
The hypothesis is that the intervention will promote adherence to the Mediterranean Diet. The second hypothesis is that adherence will be associated with alleviation of fatigue and improvements in metabolic and mitochondrial function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
The Number of Patients Who Enrolled Completed the Study.
时间窗: 8 weeks
To assess feasibility of the study, we will report what percentage of patients who enrolled completed the study.
Scores From the 14-item Mediterranean Diet Questionnaire
时间窗: 8 weeks
In order to assess adherence to the diet, we will report scores from the 14-item Mediterranean Diet questionnaire at 8 weeks. Scores range from 0 to 14 points. A higher score indicates greater adherence to the Mediterranean Diet.
次要结局
- The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire(8 weeks)
- The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire, Fatigue Subscale(8 weeks)
研究者
Luke Peppone
Associate Professor
University of Rochester