Green Tea and Reduction of Breast Cancer Risk
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | July 2009 |
| End Date: | June 2014 |
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
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.
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.
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.
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
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