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Alcohol and Breast Cancer (ABC) Trial

Primary Purpose

ER+ Breast Cancer, Breast Cancer, Aromatase Inhibitors

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
White Wine
Grape Juice
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for ER+ Breast Cancer focused on measuring ER+ Breast Cancer, Breast Cancer, Aromatase Inhibitors, Anastrozole, Letrozole, Exemestane

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

WHITE WINE FOLLOWED BY WHITE GRAPE JUICE

WHITE GRAPE JUICE FOLLOWED BY WHITE WINE

Arm Description

Participants will be randomized into one of the study drinking sequence groups: white wine followed by white grape juice or white grape juice followed by white wine. 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. -3 weeks of daily white wine followed by 3 weeks of daily white grape juice

Participants will be randomized into one of the study drinking sequence groups: white grape juice followed by white wine. 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. - 3 weeks of daily white grape juice followed by 3 weeks of daily white wine

Outcomes

Primary Outcome Measures

Blood levels of free estradiol after daily white wine
LC-MS assay

Secondary Outcome Measures

Blood levels of estrone after daily white wine
LC-MS assay
Blood levels of sex hormone binding globulin (SHBG) after daily white wine
Chemiluminescence assay
Blood levels of dehydroepiandrosterone sulfate (DHEAS) after daily white wine
Chemiluminescence assay
Blood levels of testosterone after daily white wine
LC-MS assay

Full Information

First Posted
June 14, 2022
Last Updated
August 10, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05423730
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ER+ Breast Cancer, Breast Cancer, Aromatase Inhibitors
Keywords
ER+ Breast Cancer, Breast Cancer, Aromatase Inhibitors, Anastrozole, Letrozole, Exemestane

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WHITE WINE FOLLOWED BY WHITE GRAPE JUICE
Arm Type
Experimental
Arm Description
Participants will be randomized into one of the study drinking sequence groups: white wine followed by white grape juice or white grape juice followed by white wine. 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. -3 weeks of daily white wine followed by 3 weeks of daily white grape juice
Arm Title
WHITE GRAPE JUICE FOLLOWED BY WHITE WINE
Arm Type
Experimental
Arm Description
Participants will be randomized into one of the study drinking sequence groups: white grape juice followed by white wine. 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. - 3 weeks of daily white grape juice followed by 3 weeks of daily white wine
Intervention Type
Other
Intervention Name(s)
White Wine
Intervention Description
One serving (5 ounces) of white wine daily for 3 weeks
Intervention Type
Other
Intervention Name(s)
Grape Juice
Intervention Description
One serving (6 ounces) of white grape juice daily for 3 weeks
Primary Outcome Measure Information:
Title
Blood levels of free estradiol after daily white wine
Description
LC-MS assay
Time Frame
3 Weeks
Secondary Outcome Measure Information:
Title
Blood levels of estrone after daily white wine
Description
LC-MS assay
Time Frame
3 weeks
Title
Blood levels of sex hormone binding globulin (SHBG) after daily white wine
Description
Chemiluminescence assay
Time Frame
3 Weeks
Title
Blood levels of dehydroepiandrosterone sulfate (DHEAS) after daily white wine
Description
Chemiluminescence assay
Time Frame
3 Weeks
Title
Blood levels of testosterone after daily white wine
Description
LC-MS assay
Time Frame
3 Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Mukamal, MD, MPH
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

Learn more about this trial

Alcohol and Breast Cancer (ABC) Trial

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