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Green Tea in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00949923
Recruitment Status : Active, not recruiting
First Posted : July 31, 2009
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment
Incident Breast Cancer Dietary Supplement: tea capsule

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Green Tea Supplement in Women With Incident Breast Cancer
Actual Study Start Date : May 7, 2008
Primary Completion Date : December 14, 2010
Estimated Study Completion Date : December 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: tea capsules
3 tea capsules daily for 3 weeks
Dietary Supplement: tea capsule
3 tea capsules daily for 3 weeks
Other Name: Green Tea Mega EGCG, ProHealth, Inc
No Intervention: Control
No tea capsules

Primary Outcome Measures :
  1. level of reduction in proliferation or increase in apoptosis in association with short-term EGCG [ Time Frame: At surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949923

United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Principal Investigator: Anna Wu, PhD University of Southern California

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00949923     History of Changes
Other Study ID Numbers: 1B-08-1
First Posted: July 31, 2009    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Southern California:
Postmenopausal women
Suspicious for breast ca

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases