Effect of Light Alcohol Intake on Sex Hormone Levels Among Postmenopausal Women With ER+ Breast Cancer on Aromatase Inhibitor Therapy: The Alcohol and Breast Cancer (ABC) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Blood Levels of Total Estradiol Concentration
研究概览
简要总结
This research study is a pilot study, which is the first time investigators are examining the effect of light alcohol consumption on sex hormones among postmenopausal women with estrogen receptor-positive (ER+) breast cancer taking an aromatase inhibitor
The names of the study exposures involved in this study are:
- White wine
- White grape juice
详细描述
This research study is trying to to help understand whether light alcohol consumption causes short-term changes in the levels of estrogen, progesterone and testosterone, called sex hormones, among postmenopausal women with estrogen and/or progesterone receptor positive breast cancer taking estrogen-blocking medications called aromatase inhibitors.
The research study procedures include one screening visit to obtain informed consent, four study visits with blood draws, and ten weekly phone calls and online questionnaires over the ten weeks of the study.
This research study involves 10 weeks of participation, including 3 weeks consuming one serving of white wine daily, 3 weeks consuming one serving of white grape juice daily, and 2 weeks of drinking neither alcohol nor grape juice before each of these 3-week drinking periods.
In this experimental study, participants will be asked to drink white wine and white grape juice, which are not consumed as the standard of care. The U.S. Food and Drug Administration (FDA) has not approved alcohol as a treatment for any disease.
It is expected that about 20 women will take part in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ER+ breast cancer
- •Female sex at birth
- •Postmenopausal, either natural or induced
- •Self-reported consumption of at least one alcoholic drink per week but not more than one serving per day
- •Currently prescribed aromatase inhibitors including anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®)
- •Documented liver function test results below 1.5X the upper limit of normal within 12 months of screening
排除标准
- •Self-reported consumption of more than one drink per day, a previous or current history of alcohol abuse based on standard questionnaires (AUDIT≥8), or consumption of more than 4 or more drinks in one day within the last 6 months
- •Currently undergoing cytotoxic chemotherapy or radiation or planned in the next two months
- •Any surgery planned in the next two months
- •Alcohol flushing syndrome
- •Current use of any pharmaceutical agent contraindicated with alcohol, including warfarin, dual antiplatelet therapy, and metronidazole
- •Hemoglobin A1c>8% or a fasting glucose result above 180 mg/dL within 6 months of screening
- •Unable to speak or understand English
- •Unable to understand and provide informed consent, as judged by the study team
结局指标
主要结局
Blood Levels of Total Estradiol Concentration
时间窗: 3 Weeks
Blood levels were measured at the beginning and end of three weeks of one serving (5 ounces) of white wine daily and the beginning and end of three weeks of one serving of white grape juice (6 oz) daily, with a two-week washout period before each drinking period. Estimates for levels following three weeks adjusted for blood levels at the beginning of the drinking period.
次要结局
- Blood Levels of Free Estradiol Concentration(3 weeks)
- Blood Levels of Free Estradiol Index(3 weeks)
- Blood Levels of Estrone Concentration(3 weeks)
- Blood Levels of Dehydroepiandrosterone Sulfate (DHEAS)(3 Weeks)
- Blood Levels of Testosterone(3 Weeks)
- Blood Levels of Sex Hormone Binding Globulin (SHBG)(3 Weeks)
研究者
Kenneth Mukamal
Principal Investigator
Beth Israel Deaconess Medical Center