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Green Tea and Reduction of Breast Cancer Risk

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Green tea extract supplement
Placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Green tea, Breast cancer, Prevention, COMT genotype, EGCG (Epigallocatechin gallate), Mammographic density, Reproductive hormones, IGF axis proteins, Oxidative stress

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Fairview Southdale Breast Center
  • Fairview Maple Grove Breast Center
  • University of Minnesota Medical Center (UMMC) Breast Clinic
  • Park Nicollet Institute
  • Food Science and Nutrition, University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Green tea extract

Sugar pill

Arm Description

Green tea extract capsules containing 80.7 % total catechins (51.7 % EGCG)

Placebo capsules containing 50% maltodextrin, 49.5 % cellulose, and 0.5 % magnesium stearate

Outcomes

Primary Outcome Measures

Mammographic Density
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)
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
Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.

Secondary Outcome Measures

Full Information

First Posted
June 8, 2009
Last Updated
January 25, 2016
Sponsor
University of Minnesota
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00917735
Brief Title
Green Tea and Reduction of Breast Cancer Risk
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 Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Green tea, Breast cancer, Prevention, COMT genotype, EGCG (Epigallocatechin gallate), Mammographic density, Reproductive hormones, IGF axis proteins, Oxidative stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1075 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Green tea extract
Arm Type
Experimental
Arm Description
Green tea extract capsules containing 80.7 % total catechins (51.7 % EGCG)
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo capsules containing 50% maltodextrin, 49.5 % cellulose, and 0.5 % magnesium stearate
Intervention Type
Drug
Intervention Name(s)
Green tea extract supplement
Other Intervention Name(s)
Green tea extract: Corban green tea blend (GTB-3D)
Intervention Description
Two green tea extract capsules twice daily after breakfast and dinner for one year
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
Two placebo capsules twice daily after breakfast and dinner for one year
Primary Outcome Measure Information:
Title
Mammographic Density
Description
Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.
Time Frame
Baseline and month 12
Title
Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Description
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.
Time Frame
Baseline and month 12
Title
Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3
Description
Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.
Time Frame
Baseline and month 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mindy S Kurzer, Ph.D
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fairview Southdale Breast Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Fairview Maple Grove Breast Center
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Facility Name
University of Minnesota Medical Center (UMMC) Breast Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Park Nicollet Institute
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Food Science and Nutrition, University of Minnesota
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30926986
Citation
Samavat H, Wu AH, Ursin G, Torkelson CJ, Wang R, Yu MC, Yee D, Kurzer MS, Yuan JM. Green Tea Catechin Extract Supplementation Does Not Influence Circulating Sex Hormones and Insulin-Like Growth Factor Axis Proteins in a Randomized Controlled Trial of Postmenopausal Women at High Risk of Breast Cancer. J Nutr. 2019 Apr 1;149(4):619-627. doi: 10.1093/jn/nxy316.
Results Reference
derived
PubMed Identifier
28747487
Citation
Arikawa AY, Samavat H, Gross M, Kurzer MS. Plasma F2-isoprostanes Are Positively Associated with Glycemic Load, but Inversely Associated with Dietary Polyunsaturated Fatty Acids and Insoluble Fiber in Postmenopausal Women. J Nutr. 2017 Sep;147(9):1693-1699. doi: 10.3945/jn.117.254631. Epub 2017 Jul 26.
Results Reference
derived
PubMed Identifier
27806972
Citation
Samavat H, Newman AR, Wang R, Yuan JM, Wu AH, Kurzer MS. Effects of green tea catechin extract on serum lipids in postmenopausal women: a randomized, placebo-controlled clinical trial. Am J Clin Nutr. 2016 Dec;104(6):1671-1682. doi: 10.3945/ajcn.116.137075. Epub 2016 Nov 2.
Results Reference
derived
PubMed Identifier
26701796
Citation
Dostal AM, Arikawa A, Espejo L, Kurzer MS. Long-Term Supplementation of Green Tea Extract Does Not Modify Adiposity or Bone Mineral Density in a Randomized Trial of Overweight and Obese Postmenopausal Women. J Nutr. 2016 Feb;146(2):256-64. doi: 10.3945/jn.115.219238. Epub 2015 Dec 23.
Results Reference
derived
PubMed Identifier
26581683
Citation
Dostal AM, Samavat H, Espejo L, Arikawa AY, Stendell-Hollis NR, Kurzer MS. Green Tea Extract and Catechol-O-Methyltransferase Genotype Modify Fasting Serum Insulin and Plasma Adiponectin Concentrations in a Randomized Controlled Trial of Overweight and Obese Postmenopausal Women. J Nutr. 2016 Jan;146(1):38-45. doi: 10.3945/jn.115.222414. Epub 2015 Nov 18.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/26206423
Description
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
URL
http://www.ncbi.nlm.nih.gov/pubmed/26051348
Description
The safety of green tea extract supplementation in postmenopausal women at risk for breast cancer: results of the Minnesota Green Tea Trial

Learn more about this trial

Green Tea and Reduction of Breast Cancer Risk

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