Status:
COMPLETED
Green Tea and Reduction of Breast Cancer Risk
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
50-70 years
Phase:
PHASE2
Brief Summary
RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer. PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast ...
Detailed Description
OBJECTIVES: 1. Primary: 1.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following recognized biomarkers of breast cancer risk: ...
Eligibility Criteria
Inclusion
- Signed informed consent
- Healthy postmenopausal women aged 50-70 years
- "Heterogeneously dense" (51-75% glandular) or "extremely dense" (\>75%glandular) breasts
- Willing to avoid consumption of green tea for 1 year
Exclusion
- Positive serological markers of hepatitis B or hepatitis C infections
- Elevated levels of liver enzymes
- Recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, SERMS and aromatase inhibitors
- Current smoker of cigarettes or other tobacco products
- BMI \<19 or \>40 kg/m2
- Weight change \> 10 lbs during the previous year
- History of breast cancer or proliferative breast disease
- Regular consumption of \> 7 alcoholic drinks/wk
- Regular consumption of green tea (\>1 cup/wk)
- Recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors
- Participation in any weight loss or weight gain studies
- Currently taking Methotrexate or Enbrel
- History of ovarian cancer
- Any form of cancer in the last 5 years
- Presence of implants
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
1075 Patients enrolled
Trial Details
Trial ID
NCT00917735
Start Date
July 1 2009
End Date
June 1 2014
Last Update
February 22 2016
Active Locations (5)
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1
Fairview Southdale Breast Center
Edina, Minnesota, United States, 55435
2
Fairview Maple Grove Breast Center
Maple Grove, Minnesota, United States, 55369
3
University of Minnesota Medical Center (UMMC) Breast Clinic
Minneapolis, Minnesota, United States, 55455
4
Park Nicollet Institute
Saint Louis Park, Minnesota, United States, 55426