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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,075
- 试验地点
- 5
- 主要终点
- Mammographic Density
研究概览
简要总结
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.
详细描述
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. 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Green tea extract
Green tea extract capsules containing 80.7 % total catechins (51.7 % EGCG)
干预措施: Green tea extract supplement (Drug)
Sugar pill
Placebo capsules containing 50% maltodextrin, 49.5 % cellulose, and 0.5 % magnesium stearate
干预措施: Placebo (Other)
结局指标
主要结局
Mammographic Density
时间窗: Baseline and month 12
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)
时间窗: Baseline and month 12
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
时间窗: Baseline and month 12
Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.
次要结局
未报告次要终点