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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


Phase 2
50 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

July 2013

Safety Issue:

No

Principal Investigator

Mindy S Kurzer, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota - Clinical and Translational Science Institute

Authority:

United States: Food and Drug Administration

Study ID:

0806M36121

NCT ID:

NCT00917735

Start Date:

July 2009

Completion Date:

June 2014

Related Keywords:

  • Breast Cancer
  • Green tea
  • Breast cancer
  • Prevention
  • COMT genotype
  • EGCG (Epigallocatechin gallate)
  • Mammographic density
  • Reproductive hormones
  • IGF axis proteins
  • Oxidative stress
  • Breast Neoplasms

Name

Location

Park Nicollet InstituteSt Louis Park, Minnesota  55416
Fairview Southdale Breast CenterEdina, Minnesota  55435
Fairview Maple Grove Breast CenterMaple Grove, Minnesota  55369
University of Minnesota Medical Center (UMMC) Breast ClinicMinneapolis, Minnesota  55455
Food Science and Nutrition, University of MinnesotaSt. Paul, Minnesota  55108