Alcohol and Breast Cancer (ABC) Trial

Not Applicable

Completed

• Conditions: Breast Cancer; ER+ Breast Cancer; Aromatase Inhibitors
• Interventions: Other: White Wine; Other: Grape Juice

• Registration Number: NCT05423730
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Study Start: 2022-09-01
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2024-11
• Results First Submitted: 2024-11-28
• Results First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Results First Posted: 2024-12-20
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
WHITE WINE FOLLOWED BY WHITE GRAPE JUICE	White Wine	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
WHITE GRAPE JUICE FOLLOWED BY WHITE WINE	Grape Juice	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
WHITE WINE FOLLOWED BY WHITE GRAPE JUICE	Grape Juice	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
WHITE GRAPE JUICE FOLLOWED BY WHITE WINE	White Wine	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

Primary Outcome Measures

Name	Time	Method
Blood Levels of Total Estradiol Concentration	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.

Secondary Outcome Measures

Name	Time	Method
Blood Levels of Free Estradiol Concentration	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. Estimates of free estradiol concentration were calculated using Mazer transformation.
Blood Levels of Free Estradiol Index	3 weeks	Estimated as total estradiol concentration divided by SHBG levels.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.
Blood Levels of Estrone Concentration	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.
Blood Levels of Dehydroepiandrosterone Sulfate (DHEAS)	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.
Blood Levels of Testosterone	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.
Blood Levels of Sex Hormone Binding Globulin (SHBG)	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.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States