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Alcohol and Breast Cancer (ABC) Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05423730
Recruitment Status : Not yet recruiting
First Posted : June 21, 2022
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Kenneth Mukamal, MD, Beth Israel Deaconess Medical Center

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

Condition or disease Intervention/treatment Phase
ER+ Breast Cancer Breast Cancer Aromatase Inhibitors Other: White Wine Other: Grape Juice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : August 9, 2022
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: WHITE WINE FOLLOWED BY WHITE GRAPE JUICE

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

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

Experimental: WHITE GRAPE JUICE FOLLOWED BY WHITE WINE

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

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




Primary Outcome Measures :
  1. Blood levels of free estradiol after daily white wine [ Time Frame: 3 Weeks ]
    LC-MS assay


Secondary Outcome Measures :
  1. Blood levels of estrone after daily white wine [ Time Frame: 3 weeks ]
    LC-MS assay

  2. Blood levels of sex hormone binding globulin (SHBG) after daily white wine [ Time Frame: 3 Weeks ]
    Chemiluminescence assay

  3. Blood levels of dehydroepiandrosterone sulfate (DHEAS) after daily white wine [ Time Frame: 3 Weeks ]
    Chemiluminescence assay

  4. Blood levels of testosterone after daily white wine [ Time Frame: 3 Weeks ]
    LC-MS assay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05423730


Contacts
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Contact: Kenneth Mukamal, MD, MPH (617) 754-1409 kmukamal@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Contact: Kenneth Mukamal, MD, MPH    617-754-1409    kmukamal@bidmc.harvard.edu   
Principal Investigator: Kenneth Mukamal, MD, MPH         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Kenneth Mukamal, MD, MPH Beth Israel Deaconess Medical Center
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Responsible Party: Kenneth Mukamal, MD, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT05423730    
Other Study ID Numbers: 21-698
K01AA027831 ( U.S. NIH Grant/Contract )
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kenneth Mukamal, MD, Beth Israel Deaconess Medical Center:
ER+ Breast Cancer
Breast Cancer
Aromatase Inhibitors
Anastrozole
Letrozole
Exemestane
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases