NCT05423730

Alcohol and Breast Cancer (ABC) Trial

Effect of Light Alcohol Intake on Sex Hormone Levels Among Postmenopausal Women With ER+ Breast Cancer on Aromatase Inhibitor Therapy: The Alcohol and Breast Cancer (ABC) Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Female
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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-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

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

• ER+ Breast Cancer
• Breast Cancer
• Aromatase Inhibitors

Interventions

Type	Name	Description
OTHER	White Wine	One serving (5 ounces) of white wine daily for 3 weeks
OTHER	Grape Juice	One serving (6 ounces) of white grape juice daily for 3 weeks

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2022-06-21
• Last updated: 2024-12-20
• Results posted: 2024-12-20

Locations

1 site across 1 country: United States