A Study Evaluating the Effect of Flaxseed on Biomarkers of Breast Cancer Risk
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Alteration in intermediate biomarkers of breast cancer risk at baseline and at 1, 3, and 6 months
研究概览
简要总结
RATIONALE: Ground flaxseed may prevent breast cancer in premenopausal women at increased risk of developing primary breast cancer.
PURPOSE: This randomized clinical trial is studying how well flaxseed works in preventing breast cancer in premenopausal women at risk of breast cancer.
详细描述
OBJECTIVES:
Primary aims:
-
Determine if 25 grams of flaxseed supplementation daily
-
modifies proliferation (ki-67) and apoptotic rates after six months
-
modifies expression of estrogen regulated genes: Cyclin D1, survivin, and VEGF at six months
-
modifies serum IGF-1 and serum binding protein (IGFBP)-3 levels from baseline to 6 months
-
and evaluate the feasibility and tolerability of flaxseed consumption, and determine factors that lead to decreased compliance
STUDY OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Female
- 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
Alteration in intermediate biomarkers of breast cancer risk at baseline and at 1, 3, and 6 months
时间窗: 6 months
次要结局
- Tolerability and compliance(6 months)