Alcohol and Breast Cancer (ABC) Trial

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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ER+ Breast Cancer, Breast Cancer, Aromatase Inhibitors

Intervention / Treatment
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* Other: White Wine
* Other: Grape Juice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WHITE WINE FOLLOWED BY WHITE GRAPE JUICE<br>Participants will be randomized into one of the study drinking sequence groups: white wine followed by white grape juice or white grape juice followed by white wine. 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. -3 weeks of daily white wine followed by 3 weeks of daily white grape juice | Other: White Wine<br>* One serving (5 ounces) of white wine daily for 3 weeks<br>Other: Grape Juice<br>* One serving (6 ounces) of white grape juice daily for 3 weeks<br>|
| Experimental: WHITE GRAPE JUICE FOLLOWED BY WHITE WINE<br>Participants will be randomized into one of the study drinking sequence groups: white grape juice followed by white wine. 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. - 3 weeks of daily white grape juice followed by 3 weeks of daily white wine | Other: White Wine<br>* One serving (5 ounces) of white wine daily for 3 weeks<br>Other: Grape Juice<br>* One serving (6 ounces) of white grape juice daily for 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of free estradiol after daily white wine | LC-MS assay | 3 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of estrone after daily white wine | LC-MS assay | 3 weeks | 
| Blood levels of sex hormone binding globulin (SHBG) after daily white wine | Chemiluminescence assay | 3 Weeks | 
| Blood levels of dehydroepiandrosterone sulfate (DHEAS) after daily white wine | Chemiluminescence assay | 3 Weeks | 
| Blood levels of testosterone after daily white wine | LC-MS assay | 3 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ER+ Breast Cancer, Breast Cancer, Aromatase Inhibitors, Anastrozole, Letrozole, Exemestane