Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K01AA027831 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Dana-Farber Cancer Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| White Wine | Other | One serving (5 ounces) of white wine daily for 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenneth Mukamal, MD, MPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39789640 | Derived | 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. |
Not provided
Not provided
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.
Data can be shared no earlier than 1 year following the date of publication
BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
Not provided
Twenty-three participants consented to participate. Two participants drank too much to be eligible for the trial, and one declined to participate. All twenty women who were randomized completed the trial and are included in the analyses.
We sent invitation letters to women taking AIs who received outpatient care at Beth Israel Deaconess Medical Center. Participants completed the study between September 2022 and July 2023.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 White Wine: One serving (5 ounces) of white wine daily for 3 weeks Grape Juice: One serving (6 ounces) of white grape juice daily for 3 weeks |
| FG001 | 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 White Wine: One serving (5 ounces) of white wine daily for 3 weeks Grape Juice: One serving (6 ounces) of white grape juice daily for 3 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Crossover of White Wine and 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 White Wine: One serving (5 ounces) of white wine daily for 3 weeks Grape Juice: One serving (6 ounces) of white grape juice daily for 3 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | We imputed values for estradiol below the lower limit of detection (0.5 pg/mL ) at one-half of that value. No other hormones fell below that value. | Posted | Least Squares Mean | 95% Confidence Interval | Log scale, pg/mL | 3 Weeks |
|
10 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | White Wine | One serving (5 ounces) of white wine daily for 3 weeks | 0 |
Not provided
Not provided
This was a pilot trial with a small sample size and short treatment and washout periods.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth J Mukamal | Beth Israel Deaconess Medical Center | 617-754-1401 | kmukamal@hsph.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 19, 2024 | Nov 28, 2024 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Grape Juice | Other | One serving (6 ounces) of white grape juice daily for 3 weeks |
|
| 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. | 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. | 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. | 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. | 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. | 3 Weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Total Estradiol Concentration | Median | Inter-Quartile Range | pg/mL |
|
| Free Estradiol Concentration | Median | Inter-Quartile Range | pg/mL |
|
| Free Estradiol Index | Median | Inter-Quartile Range | pg/mL |
|
| Estrone | Median | Inter-Quartile Range | pg/mL |
|
| Dehydroepiandrosterone Sulfate (DHEAS) | Median | Inter-Quartile Range | ug/dL |
|
| Testosterone | Median | Inter-Quartile Range | ng/dL |
|
| Sex hormone-binding globulin (SHBG) | Median | Inter-Quartile Range | nmol/L |
|
One serving (6 ounces) of white grape juice daily for 3 weeks |
|
|
|
| Secondary | 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. | We imputed values for estradiol below the lower limit of detection (0.5 pg/mL ) at one-half of that value. No other hormones fell below that value. | Posted | Least Squares Mean | 95% Confidence Interval | Log scale, pg/mL | 3 weeks |
|
|
|
|
| Secondary | 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. | We imputed values for estradiol below the lower limit of detection (0.5 pg/mL ) at one-half of that value. No other hormones fell below that value. | Posted | Least Squares Mean | 95% Confidence Interval | Log scale, pg/mL | 3 weeks |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Log scale, pg/mL | 3 weeks |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Log scale, ug/dL | 3 Weeks |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Log scale, ng/dL | 3 Weeks |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Log scale, nmol/L | 3 Weeks |
|
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | White Grape Juice | One serving (6 ounces) of white grape juice daily for 3 weeks | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |