Green Tea and Reduction of Breast Cancer Risk - Full Text View

Sponsor:	University of Minnesota - Clinical and Translational Science Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00917735

Purpose

RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer.

PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density.

The investigators have hypothesized that green tea consumption reduces breast cancer risk, and this effect is seen primarily in women who have the low-activity COMT genotype. The investigators will test this by evaluating the effects of green tea extract on breast cancer biomarkers including mammographic density, plasma insulin-like growth factor 1 (IGF-1), IGF binding protein 3 (IGFBP-3), estrone, estradiol, androstenedione, sex hormone binding globulin (SHBG), urinary estrogen metabolites and plasma F2-isoprostanes.

Condition	Intervention	Phase
Breast Cancer	Drug: Green tea extract supplement Other: Placebo	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Phase II, Randomized,Double-blind, Placebo-controlled, Study of the Efficacy of Green Tea Extract on Biomarkers of Breast Cancer Risk in High Risk Women With Differing Catechol-O-methyl Transferase (COMT) Genotypes

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

Mammographic density, circulating concentrations of reproductive hormones including estrone, estradiol, androstenedione and sex hormone binding globulin (SHBG) as well as IGF axis proteins including IGF-1 and IGFBP-3 [ Time Frame: July 2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Urinary estrogen metabolites, circulating concentrations of F2-isoprostanes, and circulating and urinary concentrations of catechins [ Time Frame: July 2013 ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	July 2009
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Green tea extract: Experimental	Drug: Green tea extract supplement Two green tea extract capsules twice daily after breakfast and dinner for one year
Sugar pill: Placebo Comparator	Other: Placebo Two placebo capsules twice daily after breakfast and dinner for one year

Detailed Description:

OBJECTIVES:

Primary:

1.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following recognized biomarkers of breast cancer risk:
1. Mammographic density
2. Circulating concentrations of insulin-like growth factor 1 (IGF-1) and IGF binding protein 3 (IGFBP-3)
3. Circulating concentrations of reproductive hormones (estrone, estradiol, androstenedione) and sex hormone binding globulin (SHBG)
1.2 To determine the effects of COMT genotype on the green tea extract effects described above.
Secondary:

2.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following hypothesized biomarkers of breast cancer risk:

Urinary estrogen metabolites (estrone, estradiol, and their 2-hydroxy, 4-hydroxy, 2-methoxy, and 4-methoxy metabolites, estriol, and 16- hydroxyestrone)
Circulating concentrations of F-2 isoprostanes, a recognized biomarker of systemic oxidative stress

2.2 To determine the effects of COMT genotype on the green tea extract effects described above.

2.3 To determine the effects of COMT genotype on catechin metabolism and excretion, as measured by circulating and urinary concentrations.

Eligibility

Ages Eligible for Study:	50 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Signed informed consent
Healthy postmenopausal women aged 50-70 years
"Heterogeneously dense" (51-75% glandular) or "extremely dense" (>75%glandular) breasts
Willing to avoid consumption of tea/other catechin containing foods (i.e. dark chocolate) for 1 year

Exclusion Criteria:

Positive serological markers of hepatitis B or hepatitis C infections
Elevated levels of liver enzymes
Recent (within 6 mo) or current hormone or hormone modification therapy, including hormone replacement therapy, SERMS and aromatase inhibitors
Current smoker of cigarettes or other tobacco products
BMI <19 or >35 kg/m2
Weight change > 10 lbs during the previous year
History of breast cancer or proliferative breast disease
Regular consumption of > 7 alcoholic drinks/wk
Regular consumption of green tea (>1 cup/wk)
Recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917735

Contacts

Contact: Hamed Samavat, BSc	612-624-3412 ext 3	samav005@umn.edu
Contact: Cheryl Ainslie, BSc	612-624-3412	ainsl007@umn.edu

Locations

United States, Minnesota
University of Minnesota Medical Center (UMMC) Breast Clinic	Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Mindy S Kurzer, Ph.D
Food Science and Nutrition, University of Minnesota	Recruiting
St. Paul, Minnesota, United States, 55108
Contact: Mindy S Kurzer, Ph.D 612-624-9789 mkurzer@umn.edu
Contact: Hamed Samavat, B.Sc 612-624-3412 ext 3 samav005@umn.edu
Principal Investigator: Mindy S Kurzer, Ph.D

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Mindy S Kurzer, Ph.D

University of Minnesota - Clinical and Translational Science Institute

More Information

Additional Information:

Study website containing information for the research project and recruting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Minnesota ( Dr. Mindy Kurzer )
Study ID Numbers:	0806M36121
Study First Received:	June 8, 2009
Last Updated:	August 12, 2009
ClinicalTrials.gov Identifier:	NCT00917735 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:

Green tea
Breast cancer
Prevention
COMT genotype
EGCG (Epigallocatechin gallate)

Mammographic density
Reproductive hormones
IGF axis proteins
Oxidative stress

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010