Alcohol and Breast Cancer (ABC) Trial

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05423730
• Other study ID #: 21-698
• Secondary ID: K01AA027831
• Status: Completed
• Phase: Early Phase 1
• Start date: September 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: January 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aromatase Inhibitors
• Breast Cancer
• Breast Neoplasms
• ER+ Breast Cancer

Intervention

Other:
• White Wine
One serving (5 ounces) of white wine daily for 3 weeks
• Grape Juice
One serving (6 ounces) of white grape juice daily for 3 weeks

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Dana-Farber Cancer Institute, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood levels of free estradiol after daily white wine	LC-MS assay	3 Weeks
Secondary	Blood levels of estrone after daily white wine	LC-MS assay	3 weeks
Secondary	Blood levels of sex hormone binding globulin (SHBG) after daily white wine	Chemiluminescence assay	3 Weeks
Secondary	Blood levels of dehydroepiandrosterone sulfate (DHEAS) after daily white wine	Chemiluminescence assay	3 Weeks
Secondary	Blood levels of testosterone after daily white wine	LC-MS assay	3 Weeks