NCT05423730

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 20, 2024

Completed
Last Updated

December 20, 2024

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

June 14, 2022

Results QC Date

November 28, 2024

Last Update Submit

November 28, 2024

Conditions

ER+ Breast CancerBreast CancerAromatase Inhibitors

Keywords

ER+ Breast CancerBreast CancerAromatase InhibitorsAnastrozoleLetrozoleExemestane

Outcome Measures

Primary Outcomes (1)

  • Blood Levels of Total Estradiol Concentration

    Blood levels were measured at the beginning and end of three weeks of one serving (5 ounces) of white wine daily and the beginning and end of three weeks of one serving of white grape juice (6 oz) daily, with a two-week washout period before each drinking period. Estimates for levels following three weeks adjusted for blood levels at the beginning of the drinking period.

    3 Weeks

Secondary Outcomes (6)

  • Blood Levels of Free Estradiol Concentration

    3 weeks

  • Blood Levels of Free Estradiol Index

    3 weeks

  • Blood Levels of Estrone Concentration

    3 weeks

  • Blood Levels of Dehydroepiandrosterone Sulfate (DHEAS)

    3 Weeks

  • Blood Levels of Testosterone

    3 Weeks

  • +1 more secondary outcomes

Study Arms (2)

WHITE WINE FOLLOWED BY WHITE GRAPE JUICE

EXPERIMENTAL

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 WineOther: Grape Juice

WHITE GRAPE JUICE FOLLOWED BY WHITE WINE

EXPERIMENTAL

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 WineOther: Grape Juice

Interventions

White WineOTHER

One serving (5 ounces) of white wine daily for 3 weeks

WHITE GRAPE JUICE FOLLOWED BY WHITE WINEWHITE WINE FOLLOWED BY WHITE GRAPE JUICE
Grape JuiceOTHER

One serving (6 ounces) of white grape juice daily for 3 weeks

WHITE GRAPE JUICE FOLLOWED BY WHITE WINEWHITE WINE FOLLOWED BY WHITE GRAPE JUICE

Eligibility Criteria

Age21 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Mostofsky E, Buring JE, Come SE, Tung NM, Zhang C, Mukamal KJ. Effect of daily alcohol intake on sex hormone levels among postmenopausal breast cancer survivors on aromatase inhibitor therapy: a randomized controlled crossover pilot study. Breast Cancer Res. 2025 Jan 9;27(1):5. doi: 10.1186/s13058-024-01940-4.

    PMID: 39789640DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

This was a pilot trial with a small sample size and short treatment and washout periods.

Results Point of Contact

Title
Kenneth J Mukamal
Organization
Beth Israel Deaconess Medical Center
kmukamal@hsph.harvard.edu
617-754-1401

Study Officials

  • Kenneth Mukamal, MD, MPH

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2022

First Posted

June 21, 2022

Study Start

September 1, 2022

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

December 20, 2024

Results First Posted

December 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, 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

Locations

US(1)