Status:
COMPLETED
Alcohol and Breast Cancer (ABC) Trial
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Dana-Farber Cancer Institute
Conditions:
ER+ Breast Cancer
Breast Cancer
Eligibility:
FEMALE
21-90 years
Phase:
NA
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-posi...
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 pos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05423730
Start Date
September 1 2022
End Date
July 31 2023
Last Update
December 20 2024
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215