Status:
COMPLETED
Green Tea in Breast Cancer Patients
Lead Sponsor:
University of Southern California
Conditions:
Incident Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 diagn...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 7 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00949923
Start Date
May 7 2008
End Date
June 6 2016
Last Update
March 30 2018
Active Locations (1)
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1
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033