Green Tea in Breast Cancer Patients

Incident Breast Cancer Clinical Trial

Official title:

Green Tea Supplement in Women With Incident Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949923
• Other study ID #: 1B-08-1
• Secondary ID: HS-07-00731
• Status: Completed
• Phase: N/A
• First received: July 29, 2009
• Last updated: March 28, 2018
• Start date: May 7, 2008
• Est. completion date: June 6, 2016

Study information

• Verified date: March 2018
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 6, 2016
• Est. primary completion date: December 14, 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Neoplasms
• Incident Breast Cancer

Intervention

Dietary Supplement:
• tea capsule
3 tea capsules daily for 3 weeks

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of reduction in proliferation or increase in apoptosis in association with short-term EGCG		At surgery