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Green Tea and Reduction of Breast Cancer Risk
This study has been completed.
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00917735
First received: June 8, 2009
Last updated: January 25, 2016
Last verified: January 2016
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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 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
Drug Information available for:
Camellia sinensis
U.S. FDA Resources
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- Mammographic Density [ Time Frame: Baseline and month 12 ]Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.
- 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.
- 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.
| Enrollment: | 1075 |
| Study Start Date: | July 2009 |
| Study Completion Date: | June 2014 |
| Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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:
- Mammographic density
- Circulating concentrations of insulin-like growth factor 1 (IGF-1) and IGF binding protein 3 (IGFBP-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 (Adult, Senior) |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917735
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917735
Locations
| 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 - 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00917735 History of Changes |
| Other Study ID Numbers: |
0806M36121 R01CA127236 ( U.S. NIH Grant/Contract ) |
| Study First Received: | June 8, 2009 |
| Results First Received: | July 29, 2015 |
| Last Updated: | January 25, 2016 |
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:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on August 18, 2017