A Pilot Presurgical Trial of Insulin Inhibition by a Ketogenic Diet in Operable Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- TUNEL comparison of each dietary intervention at surgical removal to measure change in apoptosis in tumor cells
研究概览
简要总结
Women post breast mass biopsy with ER+or ER- cancer will be randomized to two diets--goal of 45 of them to a ketogenic insulin inhibiting diet, 20 to a low fat diet with whole grains and fruits and vegetables. The initial biopsy will be evaluated along with the surgical specimen pathology to compare changes in biomarkers, particularly of proliferation (Ki-67) and apoptosis (TUNEL).
详细描述
A healthy diet has been defined in various ways. The investigators wish to compare the effects of two diets on ER positive breast cancer tissues. The diets will be administered between the time of diagnosis and the time of surgical removal. Both diets have been proposed as healthy, but differ in their composition. One constitutes a low fat diet with extra fiber, fruits and vegetable servings, while the other comprises a diet low in carbohydrate content, aiming to lower insulin secretion. Patients will be randomized to each group, with 20 assigned to the low fat arm and 45 to the low carbohydrate arm.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with biopsy proven breast cancer.
排除标准
- 未提供
研究组 & 干预措施
Low carbohydrate diet
45 subjects will receive a very low carbohydrate diet between a positive breast biopsy and surgical tumor removal
干预措施: Low carbohydrate diet (Behavioral)
Low fat diet
20 subjects will receive a lo fat diet between a positive breast biopsy and surgical tumor removal
干预措施: Low fat diet (Behavioral)
结局指标
主要结局
TUNEL comparison of each dietary intervention at surgical removal to measure change in apoptosis in tumor cells
时间窗: 2 years
Ki-67 comparison of each dietary intervention at surgical removal to measure change in proliferation of tumor cells
时间窗: 2 years
次要结局
未报告次要终点
研究者
Eugene Fine
Professor of Radiology
Albert Einstein College of Medicine