Green Tea and Reduction of Breast Cancer Risk
This study is currently recruiting participants.
Verified January 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborator:
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 14, 2013
Last verified: January 2013
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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
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, circulating concentrations of reproductive hormones including estrone, estradiol, androstenedione and sex hormone binding globulin (SHBG) as well as IGF axis proteins including IGF-1 and IGFBP-3 [ Time Frame: July 2013 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Urinary estrogen metabolites, circulating concentrations of F2-isoprostanes, and circulating and urinary concentrations of catechins [ Time Frame: July 2013 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Green tea extract |
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 GTB-3D
|
| Placebo Comparator: Sugar pill |
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 |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917735
Contacts
| Contact: Hamed Samavat, MS | 612-624-3412 | samav005@umn.edu |
| Contact: Allison Dostal, BSc | 612-624-3412 | dost0022@umn.edu |
Locations
| United States, Minnesota | |
| Fairview Southdale Breast Center | Active, not recruiting |
| Edina, Minnesota, United States, 55435 | |
| Fairview Maple Grove Breast Center | Active, not recruiting |
| Maple Grove, Minnesota, United States, 55369 | |
| University of Minnesota Medical Center (UMMC) Breast Clinic | Active, not recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Park Nicollet Institute | Enrolling by invitation |
| St. Louis Park, Minnesota, United States, 55426 | |
| Food Science and Nutrition, University of Minnesota | Recruiting |
| St. Paul, Minnesota, United States, 55108 | |
| Contact: Mindy S Kurzer, Ph.D 612-624-9789 mkurzer@umn.edu | |
| Contact: Hamed Samavat, MS 612-624-3412 ext 3 samav005@umn.edu | |
| Principal Investigator: Mindy S Kurzer, Ph.D | |
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
| Principal Investigator: | Mindy S Kurzer, Ph.D | University of Minnesota - Clinical and Translational Science Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00917735 History of Changes |
| Other Study ID Numbers: | 0806M36121 |
| Study First Received: | June 8, 2009 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 Epigallocatechin gallate Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Protective Agents Physiological Effects of Drugs Antimutagenic Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses Neuroprotective Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013