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OpenTrials
Completed

NCT Number: NCT00949923

Green Tea in Breast Cancer Patients

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.

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Key information

Conditions

Incident Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

tea capsule

Dietary Supplement

3 tea capsules daily for 3 weeks

Other names: Green Tea Mega EGCG, ProHealth, Inc

Primary outcomes

  1. level of reduction in proliferation or increase in apoptosis in association with short-term EGCG

    Time frame: At surgery

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Green Tea Supplement in Women With Incident Breast Cancer

Important dates

Study start
2008
Primary completion
2010
Study completion
2016
First posted
Jul 31, 2009
Registry last updated
Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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