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Trial record 1 of 1 for:    1B-08-1
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Green Tea in Breast Cancer Patients

This study is currently recruiting participants.
Verified March 2013 by USC/Norris Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00949923
First received: July 29, 2009
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Incident Breast Cancer
 Dietary Supplement: tea capsule
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Green Tea Supplement in Women With Incident Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by USC/Norris Comprehensive Cancer Center:

Primary Outcome Measures:
  • level of reduction in proliferation or increase in apoptosis in association with short-term EGCG [ Time Frame: At surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: June 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949923

Contacts
Contact: Anna Wu, PhD 323/865-0484 annawu@usc.edu
Contact: Rebecca Anderson, B.S. 323/865-0430 anderson_r@ccnt.usc.edu

Locations
United States, California
USC/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Anna Wu, PhD     323-865-0484     annawu@usc.edu    
Principal Investigator: Anna Wu, PhD            
Sponsors and Collaborators
USC/Norris Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00949923     History of Changes
Other Study ID Numbers: 1B-08-1, HS-07-00731
Study First Received: July 29, 2009
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by USC/Norris Comprehensive Cancer Center:
Postmenopausal women
Suspicious for breast ca

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

ClinicalTrials.gov processed this record on May 19, 2013