Recruiting • Phase NA • Stages 0, I, II, III, IV • ER positive • Surgical • Post-Menopausal • Interventional
The following is imported from ClinicalTrials.gov:
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 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.
Actual study start date:
August 9, 2022
Ages eligible for study:
0 - 999
Sexes eligible for study:
Arms and Intervention
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
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