Green Tea and Reduction of Breast Cancer Risk

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917735
• Other study ID #: 0806M36121
• Secondary ID: R01CA127236
• Status: Completed
• Phase: Phase 2
• First received: June 8, 2009
• Last updated: January 25, 2016
• Start date: July 2009
• Est. completion date: June 2014

Study information

• Verified date: January 2016
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1075
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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 green tea 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 systemic hormone replacement therapy, SERMS and aromatase inhibitors

• Current smoker of cigarettes or other tobacco products

• BMI <19 or >40 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

• Participation in any weight loss or weight gain studies

• Currently taking Methotrexate or Enbrel

• History of ovarian cancer

• Any form of cancer in the last 5 years

• Presence of implants

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Green tea extract supplement
Two green tea extract capsules twice daily after breakfast and dinner for one year

Other:
• Placebo
Two placebo capsules twice daily after breakfast and dinner for one year

Locations

Country	Name	City	State
United States	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	St. Louis Park	Minnesota
United States	Food Science and Nutrition, University of Minnesota	St. Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mammographic Density	Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.	Baseline and month 12	No
Primary	Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)	Circulating levels of reproductive hormones including estrone, estradiol, androstenedione, testosterone and SHBG were measured in fasting blood samples by liquid chromatography/tandem mass spectrometry method.	Baseline and month 12	No
Primary	Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3	Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.	Baseline and month 12	No

External Links

•   The Minnesota Green Tea Trial (MGTT), a randomized controlled trial of the efficacy of green tea extract on biomarkers of breast cancer risk: study rationale, design, methods, and participant characteristics
•   The safety of green tea extract supplementation in postmenopausal women at risk for breast cancer: results of the Minnesota Green Tea Trial