A Nutritional Intervention to Decrease Breast Density Among Female BRCA Carriers -A Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Changes in breast density compared to baseline
研究概览
简要总结
The purpose of this study is to determine whether adding DIM supplement will decrease breast density among female BRCA mutation carriers in two years.
详细描述
The Research Question: In female BRCA mutation carriers, will adding DIM (100mg*1/d, a nutritional supplement), decrease breast density in two years?
Study design: A single center single arm prospective interventional study of the use of DIM to decrease risk of breast cancer among female BRCA carriers.
Study population: Subjects will be female carriers of a BRCA mutation and have more than 10% mammographic breast density at baseline.
Intervention: DIM supplement (100mg*1/d).
Study Time line: This will be a 2 years study. At initiation a breast mammography will be performed and eligibility assessed. Follow-up visits will occur every 4 months and quality of life questionnaires as well as adherence to DIM supplementation will be assessed. At the initiation and every 4 months blood and urine samples will be collected for Estrogen profile. At 12 and 24 months a mammography will be performed to verify changes in breast density.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who carrier the BRCA 1\2 mutation.
- •No history of breast or ovarian malignancy.
- •i. Baseline mammographic breast density is more than 10% OR ii. Baseline breast MRI with density or enhancement ≤
- •Absence of any psychological, familial, sociological or geographical situation potentially hampering adherence to the study protocol and follow-up schedule.
- •Informed written consent must be signed according to ICH/EU GCP, before subject registration.
排除标准
- •Women who have undergone preventive breast reduction.
- •Breast imaging demonstrating a lesion suspected to be cancerous.
- •Breast feeding or Pregnancy or planning to get pregnant.
- •Known allergy to DIM and its ingredients.
结局指标
主要结局
Changes in breast density compared to baseline
时间窗: 0, 12 and 24 months following intiation
The amount of fibroglandular tissue (FGT) and background parenchymal enhancement (BPE) on magnetic resonance imaging (MRI)
次要结局
- Estrogen profile(0, 4, 8, 12, 16 and 24 months following initiation)
- The Estronex Profile(0, 12 and 24 months following initiation)
- change in Quality of life(0, 4, 8, 12, 16 and 24 months following initiation)