NCT00917735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,075

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Jul 2009

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 22, 2016

Completed
Last Updated

February 22, 2016

Status Verified

January 1, 2016

Enrollment Period

4.9 years

First QC Date

June 8, 2009

Results QC Date

July 29, 2015

Last Update Submit

January 25, 2016

Conditions

Breast Cancer

Keywords

Green teaBreast cancerPreventionCOMT genotypeEGCG (Epigallocatechin gallate)Mammographic densityReproductive hormonesIGF axis proteinsOxidative stress

Outcome Measures

Primary Outcomes (3)

  • Mammographic Density

    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)

    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

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

    Baseline and month 12

Study Arms (2)

Green tea extract

EXPERIMENTAL

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

Drug: Green tea extract supplement

Sugar pill

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Green tea extract supplementDRUG

Two green tea extract capsules twice daily after breakfast and dinner for one year

Also known as: Green tea extract: Corban green tea blend (GTB-3D)
Green tea extract
PlaceboOTHER

Two placebo capsules twice daily after breakfast and dinner for one year

Also known as: Sugar Pill
Sugar pill

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Fairview Southdale Breast Center

Edina, Minnesota, 55435, United States

Location

Fairview Maple Grove Breast Center

Maple Grove, Minnesota, 55369, United States

Location

University of Minnesota Medical Center (UMMC) Breast Clinic

Minneapolis, Minnesota, 55455, United States

Location

Park Nicollet Institute

Saint Louis Park, Minnesota, 55426, United States

Location

Food Science and Nutrition, University of Minnesota

Saint Paul, Minnesota, 55108, United States

Location

Related Publications (6)

  • Bathgate JR, Radler DR, Kurzer M, Samavat H. Green tea extract supplementation does not modify plasma concentration of F2-isoprostanes in women who are postmenopause: Findings from a randomized controlled trial. Nutr Res. 2023 May;113:29-38. doi: 10.1016/j.nutres.2023.03.001. Epub 2023 Mar 9.

    PMID: 37011435DERIVED

  • 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.

    PMID: 30926986DERIVED

  • 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.

    PMID: 28747487DERIVED

  • 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.

    PMID: 27806972DERIVED

  • 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.

    PMID: 26701796DERIVED

  • 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.

    PMID: 26581683DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sugars

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

We had limited success in recruiting minority populations.

Results Point of Contact

Title
Dr. Mindy Kurzer
Organization
University of Minnesota
mkurzer@umn.edu
612-624-9789

Study Officials

  • Mindy S Kurzer, Ph.D

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 10, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 22, 2016

Results First Posted

February 22, 2016

Record last verified: 2016-01

Locations

US(5)