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Green Tea and Reduction of Breast Cancer Risk

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ClinicalTrials.gov Identifier: NCT00917735
Recruitment Status : Completed
First Posted : June 10, 2009
Results First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Green tea extract supplement Other: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1075 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : July 2009
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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 Name: 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 Name: Sugar Pill


Outcome Measures
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Primary Outcome Measures :
  1. Mammographic Density [ Time Frame: Baseline and month 12 ]
    Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes 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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917735


Locations
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United States, Minnesota
Fairview Southdale Breast Center
Edina, Minnesota, United States, 55435
Fairview Maple Grove Breast Center
Maple Grove, Minnesota, United States, 55369
University of Minnesota Medical Center (UMMC) Breast Clinic
Minneapolis, Minnesota, United States, 55455
Park Nicollet Institute
St. Louis Park, Minnesota, United States, 55426
Food Science and Nutrition, University of Minnesota
St. Paul, Minnesota, United States, 55108
Sponsors and Collaborators
University of Minnesota
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mindy S Kurzer, Ph.D University of Minnesota
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT00917735    
Other Study ID Numbers: 0806M36121
R01CA127236 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2009    Key Record Dates
Results First Posted: February 22, 2016
Last Update Posted: February 22, 2016
Last Verified: January 2016
Keywords provided by University of Minnesota:
Green tea
Breast cancer
Prevention
COMT genotype
EGCG (Epigallocatechin gallate)
 Mammographic density
Reproductive hormones
IGF axis proteins
Oxidative stress
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases