Clinical trial NCT05423730: Alcohol and Breast Cancer (ABC) 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ER+ Breast Cancer
Breast Cancer
Aromatase Inhibitors
Keywords: ER+ Breast Cancer
Breast Cancer
Aromatase Inhibitors
Anastrozole
Letrozole
Exemestane
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Dana-Farber Cancer Institute
First posted: 2022-06-21
Enrollment: 23
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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-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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Levels of Total Estradiol Concentration
timeFrame: 3 Weeks
Secondary outcomes:
measure: Blood Levels of Free Estradiol Concentration
timeFrame: 3 weeks
measure: Blood Levels of Free Estradiol Index
timeFrame: 3 weeks
measure: Blood Levels of Estrone Concentration
timeFrame: 3 weeks
measure: Blood Levels of Dehydroepiandrosterone Sulfate (DHEAS)
timeFrame: 3 Weeks
measure: Blood Levels of Testosterone
timeFrame: 3 Weeks
measure: Blood Levels of Sex Hormone Binding Globulin (SHBG)
timeFrame: 3 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Kenneth Mukamal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: