NCT05423730 - Alcohol and Breast Cancer (ABC) Trial | Crick

Overview

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

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

23

Conditions

ER+ Breast Cancer Breast Cancer Aromatase Inhibitors

Interventions

White WineOTHER

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

Grape JuiceOTHER

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

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 3 Weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 3 weeks