ER+ Breast Cancer, Breast Cancer, Aromatase Inhibitors
Conditions
Keywords
ER+ Breast Cancer, Breast Cancer, Aromatase Inhibitors, Anastrozole, Letrozole, Exemestane
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.
Interventions
OTHERWhite Wine
One serving (5 ounces) of white wine daily for 3 weeks
OTHERGrape Juice
One serving (6 ounces) of white grape juice daily for 3 weeks
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Levels of Total Estradiol Concentration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Levels of Free Estradiol Index | 3 weeks | 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. |
| Blood Levels of Estrone Concentration | 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. |
| Blood Levels of Free Estradiol Concentration | 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. Estimates of free estradiol concentration were calculated using Mazer transformation. |
| Blood Levels of Testosterone | 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. |
| Blood Levels of Sex Hormone Binding Globulin (SHBG) | 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. |
| Blood Levels of Dehydroepiandrosterone Sulfate (DHEAS) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Crossover of White Wine and White Grape Juice |
|---|---|
| Age, Continuous | 61.0 years |
| Dehydroepiandrosterone Sulfate (DHEAS) | 57.5 ug/dL |
| Estrone | 0.9 pg/mL |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Free Estradiol Concentration | 0.014 pg/mL |
| Free Estradiol Index | 0.012 pg/mL |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
| Sex hormone-binding globulin (SHBG) | 56.8 nmol/L |
| Testosterone | 15.3 ng/dL |
| Total Estradiol Concentration | 0.8 pg/mL |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 3 Weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| White Wine | Blood Levels of Total Estradiol Concentration | -0.50 Log scale, pg/mL |
| White Grape Juice | Blood Levels of Total Estradiol Concentration | -0.39 Log scale, pg/mL |
95% CI: [-49.75, 57.2]
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.
Time frame: 3 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| White Wine | Blood Levels of Dehydroepiandrosterone Sulfate (DHEAS) | 4.18 Log scale, ug/dL |
| White Grape Juice | Blood Levels of Dehydroepiandrosterone Sulfate (DHEAS) | 4.08 Log scale, ug/dL |
95% CI: [-3.31, 28.4]
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.
Time frame: 3 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| White Wine | Blood Levels of Estrone Concentration | 0.03 Log scale, pg/mL |
| White Grape Juice | Blood Levels of Estrone Concentration | -0.10 Log scale, pg/mL |
95% CI: [-9.45, 43.09]
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.
Time frame: 3 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| White Wine | Blood Levels of Free Estradiol Concentration | -4.53 Log scale, pg/mL |
| White Grape Juice | Blood Levels of Free Estradiol Concentration | -4.45 Log scale, pg/mL |
95% CI: [-47.96, 63.9]
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.
Time frame: 3 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| White Wine | Blood Levels of Free Estradiol Index | -0.01 Log scale, pg/mL |
| White Grape Juice | Blood Levels of Free Estradiol Index | 0 Log scale, pg/mL |
95% CI: [-1.95, 0.67]
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.
Time frame: 3 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| White Wine | Blood Levels of Sex Hormone Binding Globulin (SHBG) | 3.87 Log scale, nmol/L |
| White Grape Juice | Blood Levels of Sex Hormone Binding Globulin (SHBG) | 3.90 Log scale, nmol/L |
95% CI: [-21.92, 21.24]
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.
Time frame: 3 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| White Wine | Blood Levels of Testosterone | 2.75 Log scale, ng/dL |
| White Grape Juice | Blood Levels of Testosterone | 2.63 Log scale, ng/dL |
95% CI: [-0.77, 27.69]