Flaxseed Lignan as a Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 180
- 试验地点
- 7
- 主要终点
- Change in Percent of Breast Epithelial Cells With Ki-67 Immunocytochemical Expression
研究概览
简要总结
The investigators will study the effect of 12 months of SDG (Brevail) vs placebo on women at increased risk for development of breast cancer.
详细描述
The investigators would like to see if women at increased risk for breast cancer are likely to tolerate SDG daily for 12 months without significant side effects or changes in their menstrual cycles. The investigators would also like to determine if Brevail® can reduce breast cell proliferation in pre-menopausal women.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
flaxseed lignan, SDG
Secoisolariciresinol diglycoside
干预措施: secoisolariciresinol (Drug)
Placebo
Matched Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Percent of Breast Epithelial Cells With Ki-67 Immunocytochemical Expression
时间窗: 12 months
Change over the course of study in the percent of breast epithelial cells expressing the proliferation marker Ki- 67/MIB-1 in hyperplastic benign breast tissue acquired by random periareolar fine needle aspiration pre-study and post-study.
次要结局
- Breast Cancer Prevention Trial (BCPT) Symptom Checklist(12 months)
- Change in Gene Expression(12 months)
研究者
Carol Fabian, MD
Professor, Director Breast Cancer Prevention Unit
University of Kansas Medical Center