Back to resultsGreen Tea in Breast Cancer Patients
Primary Purpose
Incident Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tea capsule
Sponsored by
About this trial
This is an interventional prevention trial for Incident Breast Cancer focused on measuring Postmenopausal women, Suspicious for breast ca
Eligibility Criteria
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).
Sites / Locations
- USC/Norris Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
tea capsules
Control
Arm Description
3 tea capsules daily for 3 weeks
No tea capsules
Outcomes
Primary Outcome Measures
level of reduction in proliferation or increase in apoptosis in association with short-term EGCG
Secondary Outcome Measures
Full Information
NCT ID
NCT00949923
First Posted
July 29, 2009
Last Updated
March 28, 2018
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT00949923
Brief Title
Green Tea in Breast Cancer Patients
Official Title
Green Tea Supplement in Women With Incident Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 7, 2008 (Actual)
Primary Completion Date
December 14, 2010 (Actual)
Study Completion Date
June 6, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incident Breast Cancer
Keywords
Postmenopausal women, Suspicious for breast ca
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tea capsules
Arm Type
Active Comparator
Arm Description
3 tea capsules daily for 3 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
No tea capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
tea capsule
Other Intervention Name(s)
Green Tea Mega EGCG, ProHealth, Inc
Intervention Description
3 tea capsules daily for 3 weeks
Primary Outcome Measure Information:
Title
level of reduction in proliferation or increase in apoptosis in association with short-term EGCG
Time Frame
At surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Wu, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Green Tea in Breast Cancer Patients
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