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Alcohol and Breast Cancer (ABC) Trial

NCT ID: NCT05423730

Last Updated: 2024-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-07-31

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.

Conditions

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ER+ Breast Cancer Breast Cancer Aromatase Inhibitors

Keywords

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ER+ Breast Cancer Breast Cancer Aromatase Inhibitors Anastrozole Letrozole Exemestane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

White Wine

Intervention Type OTHER

One serving (5 ounces) of white wine daily for 3 weeks

Grape Juice

Intervention Type OTHER

One serving (6 ounces) of white grape juice daily for 3 weeks

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

Group Type EXPERIMENTAL

White Wine

Intervention Type OTHER

One serving (5 ounces) of white wine daily for 3 weeks

Grape Juice

Intervention Type OTHER

One serving (6 ounces) of white grape juice daily for 3 weeks

Interventions

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White Wine

One serving (5 ounces) of white wine daily for 3 weeks

Intervention Type OTHER

Grape Juice

One serving (6 ounces) of white grape juice daily for 3 weeks

Intervention Type OTHER

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Mukamal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth Mukamal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Mostofsky E, Buring JE, Come SE, Tung NM, Zhang C, Mukamal KJ. Effect of daily alcohol intake on sex hormone levels among postmenopausal breast cancer survivors on aromatase inhibitor therapy: a randomized controlled crossover pilot study. Breast Cancer Res. 2025 Jan 9;27(1):5. doi: 10.1186/s13058-024-01940-4.

Reference Type DERIVED
PMID: 39789640 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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K01AA027831

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-698

Identifier Type: -

Identifier Source: org_study_id