Overview

This trial is active, not recruiting.

Condition incident breast cancer
Treatment tea capsule
Phase phase 1
Sponsor University of Southern California
Start date June 2008
End date June 2016
Trial size 20 participants
Trial identifier NCT00949923, 1B-08-1, HS-07-00731

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
3 tea capsules daily for 3 weeks
tea capsule Green Tea Mega EGCG, ProHealth, Inc
3 tea capsules daily for 3 weeks
(No Intervention)
No tea capsules

Primary Outcomes

Measure
level of reduction in proliferation or increase in apoptosis in association with short-term EGCG
time frame: At surgery

Eligibility Criteria

Female participants at least 18 years old.

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).

Additional Information

Official title Green Tea Supplement in Women With Incident Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Southern California.