Green Tea and Reduction of Breast Cancer Risk

January 25, 2016 updated by: University of Minnesota

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1075

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Breast Center
      • Maple Grove, Minnesota, United States, 55369
        • Fairview Maple Grove Breast Center
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center (UMMC) Breast Clinic
      • St. Louis Park, Minnesota, United States, 55426
        • Park Nicollet Institute
      • St. Paul, Minnesota, United States, 55108
        • Food Science and Nutrition, University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Green tea extract
Green tea extract capsules containing 80.7 % total catechins (51.7 % EGCG)
Drug: Green tea extract supplement
Two green tea extract capsules twice daily after breakfast and dinner for one year
Other Names:
  • Green tea extract: Corban green tea blend (GTB-3D)
Placebo Comparator: Sugar pill
Placebo capsules containing 50% maltodextrin, 49.5 % cellulose, and 0.5 % magnesium stearate
Other: Placebo
Two placebo capsules twice daily after breakfast and dinner for one year
Other Names:
  • Sugar Pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mammographic Density
Time Frame: Baseline and month 12
Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.
Baseline and month 12
Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Time Frame: Baseline and month 12
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
Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3
Time Frame: Baseline and month 12
Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.
Baseline and month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Mindy S Kurzer, Ph.D, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0806M36121
  • R01CA127236 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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