DAGMAR: Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Ki-67
研究概览
简要总结
The aim is to investigate if soy isoflavones and lignans affect markers of disease progression and gene expression among breast cancer patients receiving neo-adjuvant treatment in a three arm, double-blinded, randomized placebo-controlled trial (RCT) comparing: soy isoflavone supplementation, lignan supplementation, and placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with breast cancer at "Brystkirurgisk Afdeling" at Rigshospitalet and Herlev Hospitals (within the last 30 days).
- •Advised (and accepted) to receive neo-adjuvant treatment
- •Primary unilateral breast cancer
- •Treatment is expected to be curative
- •Is expected to be able to attend surgery
排除标准
- •Allergic to soy
- •Celiac disease
- •Inflammatory bowel disease
- •Not understanding Danish (patient material and questionnaires are in Danish)
- •Prior diagnosis of breast cancer
- •Use of dietary supplements containing lignans or isoflavones three months prior to diagnosis
研究组 & 干预措施
Lignan capsule
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
干预措施: Lignans (Dietary Supplement)
Placebo capsule
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
干预措施: Placebo (Dietary Supplement)
Isoflavones capsule
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
干预措施: Soy isoflavones (Dietary Supplement)
结局指标
主要结局
Ki-67
时间窗: Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
Ki-67 can be measured using immunohistochemistry (IHC) and using the transcript from gene expression data (see secondary outcomes). As the latter is superior and less biased, the Ki-67 based on the transcript will be used as primary measure of Ki67.
次要结局
- Patient reported outcomes(Change for completion of first questionnaire (shortly after diagnosis) to second questionnaire (close to time of surgery). Approx. four months (neo-adjuvant setting))
- Proliferation Index(Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting))
- Apoptosis marker caspase-3(Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting))
研究者
Cecilie Kyrø
Principal Investigator
Danish Cancer Society