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Green Tea in Breast Cancer Patients

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University of Southern California

关键词

抽象

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.

日期

最后验证: 02/28/2018
首次提交: 07/28/2009
提交的预估入学人数: 07/29/2009
首次发布: 07/30/2009
上次提交的更新: 03/27/2018
最近更新发布: 03/29/2018
实际学习开始日期: 05/06/2008
预计主要完成日期: 12/13/2010
预计完成日期: 06/05/2016

状况或疾病

Incident Breast Cancer

干预/治疗

Dietary Supplement: tea capsules

-

手臂组

干预/治疗
Active Comparator: tea capsules
3 tea capsules daily for 3 weeks
Dietary Supplement: tea capsules
3 tea capsules daily for 3 weeks
No Intervention: Control
No tea capsules

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别Female
接受健康志愿者
标准

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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).

结果

主要结果指标

1. level of reduction in proliferation or increase in apoptosis in association with short-term EGCG [At surgery]

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