EFFECT-BC: The EFFECT of Intermittent Fasting on Body Composition in Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Adherence to the intermittent fasting program
研究概览
简要总结
The objective of this study is to evaluate intermittent fasting after the treatment of breast cancer with surgery and radiation therapy. All participants will either delay their first meal of the day or advance their last meal to achieve an approximate 16-18 hour fasting period four times per week. Over six months, the innovative protocol will 1) assess adherence, and is expected to 2) improve body composition, quality of life and inflammatory and metabolic variables linked with outcomes after breast cancer treatment. The long-term goal of this project is to incorporate this dietary strategy as a standard component of care for breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast stage I-III
- •completed any chemotherapy prior to initiation of the trial (adjuvant endocrine therapy is permitted)
- •BMI > 25 kg/m2 or body fat% greater or equal to 31%
- •have a schedule amenable to nutrition and dietitian counseling described within the study protocol as determined by the treating radiation oncologist
- •have access to the internet and email with capability to join Zoom calls
排除标准
- •Metastatic breast cancer
- •Currently receiving chemotherapy
- •Uncontrolled hypertension or diabetes, defined as systolic blood pressure over 149, diastolic blood pressure over 99, or hemoglobin A1c greater than 8.
- •Diabetic condition requiring the usage of insulin
结局指标
主要结局
Adherence to the intermittent fasting program
时间窗: 6 months
as determined by the proportion of fasting days met divided by the total fasting days planned for each participant
Change in body fat
时间窗: baseline, 6 months
as measured by mean change in percent body fat between baseline and 6 months
次要结局
未报告次要终点