Short-term Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy: A Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Longitudinal body composition changes
研究概览
简要总结
The study aims to test the feasibility and effects of a dietary and physical activity intervention based on evolutionary considerations in an oncological setting.
详细描述
A total of 13 breast cancer patients referred to our clinic for curative radiotherapy were recruited for this pilot study. The women were supposed to undertake a "Paleolithic lifestyle" (PL) intervention consisting of a Paleolithic diet and daily outdoor activity of at least 30 min duration while undergoing radiotherapy. Body composition was measured weekly by bioimpedance analysis. Blood parameters were assessed before, during, and at the end of radiotherapy. A control group on an unspecified standard diet (SD) was assigned by propensity score matching.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Body mass index >18 kg/m^2
- •Karnofsky performance index >60
排除标准
- •Metallic body parts
- •Unable to comprehend the intervention
结局指标
主要结局
Longitudinal body composition changes
时间窗: through study completion, an average of 5 weeks
Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany)
Dropout rate in the Paleolithic lifestyle intervention group
时间窗: through study completion, an average of 5 weeks
Used to measure feasibility. The intervention is rated as feasible if dropout rate is \<30%
Change in vitamin D levels
时间窗: through study completion, an average of 5 weeks
Difference between final (average 5 weekks) and baseline 25-hydroxyvitamin D level
次要结局
- Change in beta-hydroxybutyrate levels(through study completion, an average of 5 weeks)
研究者
Dr. Rainer Klement
Principle investigator
MVZ Leopoldina GmbH