Alcohol and Breast Cancer (ABC) Trial

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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Aromatase Inhibitors; ER+ Breast Cancer
• Intervention / Treatment: Other: White Wine; Other: 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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WHITE WINE FOLLOWED BY WHITE 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	Other: White Wine; One serving (5 ounces) of white wine daily for 3 weeks; Other: Grape Juice; One serving (6 ounces) of white grape juice daily for 3 weeks
Experimental: WHITE GRAPE JUICE FOLLOWED BY 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	Other: White Wine; One serving (5 ounces) of white wine daily for 3 weeks; Other: Grape Juice; One serving (6 ounces) of white grape juice daily for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Levels of Total Estradiol Concentration	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.	3 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Levels of Free Estradiol Concentration	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.	3 weeks
Blood Levels of Free Estradiol Index	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.	3 weeks
Blood Levels of Estrone Concentration	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.	3 weeks
Blood Levels of Dehydroepiandrosterone Sulfate (DHEAS)	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.	3 Weeks
Blood Levels of Testosterone	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.	3 Weeks
Blood Levels of Sex Hormone Binding Globulin (SHBG)	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.	3 Weeks

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Kenneth Mukamal, MD, MPH, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Exemestane; Letrozole; Aromatase Inhibitors; Anastrozole; ER+ Breast Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 21-698; K01AA027831 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No