Alcohol and Breast Cancer (ABC) Trial

Beth Israel Lahey Health

Status: Completed

Conditions: Breast Cancer; Aromatase Inhibitors; ER+ Breast Cancer

Treatments: Other: White Wine; Other: Grape Juice

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05423730

21-698

K01AA027831 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 patients

Sex: Female

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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23 participants in 2 patient groups

WHITE WINE FOLLOWED BY WHITE GRAPE JUICE

Experimental group

Description:

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

Treatment:

Other: Grape Juice

Other: White Wine

WHITE GRAPE JUICE FOLLOWED BY WHITE WINE

Experimental group

Description:

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

Treatment:

Other: Grape Juice

Other: White Wine