NCT00949923已完成不适用
Green Tea Supplement in Women With Incident Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- level of reduction in proliferation or increase in apoptosis in association with short-term EGCG
研究概览
简要总结
Prognostic factors for breast cancer beyond stage at diagnosis and tumor characteristics have not been well studied. Of special interest are lifestyle factors that can be modified by women after diagnosis to increase disease-free survival. Green tea is rich in polyphenols consisting primarily of epicatechins, epigallocatechin, epicatechin gallate, and epigallocatechin gallate (EGCG). The investigators hypothesize that there will be a reduction in proliferation and/or an increase in apoptosis in association with short-term EGCG treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal (at least 2 years since last menstrual period) or age 55 or older if prior hysterectomy
- •Non-current (not with past 6 months) user of menopausal hormones
- •Mammographic abnormality consistent with any type of incident breast cancer necessitating a diagnostic biopsy (BIRAD IV(b), (c) or V) will be sufficient to draw baseline LFT and complete screening questionnaire. Unless the biopsy confirms incident breast cancer, such subjects will not be included in further research interventions and they will not serve as EGCG treated or control subjects.
- •Diagnosed with incident breast cancer on the diagnostic biopsy is required for inclusion in the EGCG or control treatment groups.
- •Non-green tea drinker (less than monthly) - this criteria does not apply to black tea or herbal tea
- •Provided written informed consent
排除标准
- •Green tea drinker (once per month or more)
- •History of breast cancer or other cancer including a prior diagnosis of any type of incident breast cancer.
- •Known allergy to tea
- •Abnormal liver enzymes (plus or minus 10% of the normal ranges).
研究组 & 干预措施
tea capsules
Active Comparator
3 tea capsules daily for 3 weeks
干预措施: tea capsule (Dietary Supplement)
Control
No Intervention
No tea capsules
结局指标
主要结局
level of reduction in proliferation or increase in apoptosis in association with short-term EGCG
时间窗: At surgery
次要结局
未报告次要终点
研究者
研究点 (2)
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