ER+ Breast CancerNCT05423730
Alcohol and Breast Cancer (ABC) Trial
A study testing White Wine and Grape Juice in people with ER+ Breast Cancer and Breast Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 90 years, women only
- Conditions the study is for
- ER+ Breast Cancer, Breast Cancer, Aromatase Inhibitors
- What is being tested?
- White Wine and Grape Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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
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
Read the 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.
- Conditions
- ER+ Breast Cancer, Breast Cancer, Aromatase Inhibitors
- Being tested
- White Wine, Grape Juice
- Keywords
- ER+ Breast Cancer, Breast Cancer, Aromatase Inhibitors, Anastrozole, Letrozole, Exemestane
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White WineOther
One serving (5 ounces) of white wine daily for 3 weeks
Grape JuiceOther
One serving (6 ounces) of white grape juice daily for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: White Wine; Other: 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 Receives: Other: White Wine; Other: Grape Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Weeks
Secondary outcomes (6)
Blood Levels of Free 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. Estimates of free estradiol concentration were calculated using Mazer transformation.
Measured: 3 weeks
Blood Levels of Free Estradiol Index
Estimated as total estradiol concentration divided by SHBG levels.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.
Measured: 3 weeks
Blood Levels of Estrone 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.
Measured: 3 weeks
Blood Levels of Dehydroepiandrosterone Sulfate (DHEAS)
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.
Measured: 3 Weeks
Blood Levels of Testosterone
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.
Measured: 3 Weeks
Blood Levels of Sex Hormone Binding Globulin (SHBG)
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.
Measured: 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Sep 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ER+ Breast CancerStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Kenneth Mukamal, Beth Israel Deaconess Medical Center
- Investigators
- Kenneth Mukamal, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423730
- Sponsor's protocol ID
- 21-698
- Other IDs
- K01AA027831
- Status last verified
- Nov 2024
- First submitted
- 14 Jun 2022
- Last updated
- 20 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39789640
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05423730
- Acronym / sponsor ID
- 21-698
- Conditions
- ER+ Breast Cancer, Breast Cancer, Aromatase Inhibitors
- Keywords
- ER+ Breast Cancer, Breast Cancer, Aromatase Inhibitors, Anastrozole, Letrozole, Exemestane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Dana-Farber Cancer Institute
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Posted 20 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WHITE WINE FOLLOWED BY WHITE GRAPE JUICE | Experimental | Other: White Wine, Other: Grape JuiceParticipants 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 |
| WHITE GRAPE JUICE FOLLOWED BY WHITE WINE | Experimental | Other: White Wine, Other: Grape JuiceParticipants 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 |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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®)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White WineOne serving (5 ounces) of white wine daily for 3 weeks | Other | WHITE GRAPE JUICE FOLLOWED BY WHITE WINE, WHITE WINE FOLLOWED BY WHITE GRAPE JUICE |
| Grape JuiceOne serving (6 ounces) of white grape juice daily for 3 weeks | Other | WHITE GRAPE JUICE FOLLOWED BY WHITE WINE, WHITE WINE FOLLOWED BY WHITE GRAPE JUICE |
Primary outcome
Blood Levels of Total Estradiol Concentration
Time frame: 3 Weeks
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.
6 secondary outcomes
Blood Levels of Free Estradiol Concentration
Time frame: 3 weeks
Blood Levels of Free Estradiol Index
Time frame: 3 weeks
Blood Levels of Estrone Concentration
Time frame: 3 weeks
Blood Levels of Dehydroepiandrosterone Sulfate (DHEAS)
Time frame: 3 Weeks
Blood Levels of Testosterone
Time frame: 3 Weeks
Blood Levels of Sex Hormone Binding Globulin (SHBG)
Time frame: 3 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39789640Mostofsky 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Mukamal, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White Wine and Grape Juice in people with ER+ Breast Cancer and Breast Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Levels of Total Estradiol Concentration (time frame: 3 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05423730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.