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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
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.
OBJECTIVES: 1. 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. 2. 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: 1. Urinary estrogen metabolites (estrone, estradiol, and their 2-hydroxy, 4-hydroxy, 2-methoxy, and 4-methoxy metabolites, estriol, and 16- hydroxyestrone) 2. 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.
Age
50 - 70 years
Sex
FEMALE
Healthy Volunteers
Yes
Fairview Southdale Breast Center
Edina, Minnesota, United States
Fairview Maple Grove Breast Center
Maple Grove, Minnesota, United States
University of Minnesota Medical Center (UMMC) Breast Clinic
Minneapolis, Minnesota, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, United States
Food Science and Nutrition, University of Minnesota
Saint Paul, Minnesota, United States
Start Date
July 1, 2009
Primary Completion Date
June 1, 2014
Completion Date
June 1, 2014
Last Updated
February 22, 2016
1,075
ACTUAL participants
Green tea extract supplement
DRUG
Placebo
OTHER
Lead Sponsor
University of Minnesota
Collaborators
NCT05372640
NCT05673200
Data Source & Attribution
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