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Trial Outcomes & Findings for Alcohol and Breast Cancer (ABC) Trial (NCT NCT05423730)

NCT ID: NCT05423730

Last Updated: 2024-12-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

3 Weeks

Results posted on

2024-12-20

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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
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
Overall Study
STARTED
9
11
Overall Study
COMPLETED
9
11
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alcohol and Breast Cancer (ABC) Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Crossover of White Wine and White Grape Juice
n=20 Participants
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
Age, Continuous
61.0 years
n=5 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
Race (NIH/OMB)
White
16 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
20 participants
n=5 Participants
Total Estradiol Concentration
0.8 pg/mL
n=5 Participants
Free Estradiol Concentration
0.014 pg/mL
n=5 Participants
Free Estradiol Index
0.012 pg/mL
n=5 Participants
Estrone
0.9 pg/mL
n=5 Participants
Dehydroepiandrosterone Sulfate (DHEAS)
57.5 ug/dL
n=5 Participants
Testosterone
15.3 ng/dL
n=5 Participants
Sex hormone-binding globulin (SHBG)
56.8 nmol/L
n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
White Wine
n=20 Participants
One serving (5 ounces) of white wine daily for 3 weeks
White Grape Juice
n=20 Participants
One serving (6 ounces) of white grape juice daily for 3 weeks
Blood Levels of Total Estradiol Concentration
-0.50 Log scale, pg/mL
Interval -1.03 to 0.02
-0.39 Log scale, pg/mL
Interval -0.91 to 0.14

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
White Wine
n=20 Participants
One serving (5 ounces) of white wine daily for 3 weeks
White Grape Juice
n=20 Participants
One serving (6 ounces) of white grape juice daily for 3 weeks
Blood Levels of Free Estradiol Concentration
-4.53 Log scale, pg/mL
Interval -5.1 to -3.96
-4.45 Log scale, pg/mL
Interval -5.03 to -3.88

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
White Wine
n=20 Participants
One serving (5 ounces) of white wine daily for 3 weeks
White Grape Juice
n=20 Participants
One serving (6 ounces) of white grape juice daily for 3 weeks
Blood Levels of Free Estradiol Index
-0.01 Log scale, pg/mL
Interval -0.03 to 0.01
0 Log scale, pg/mL
Interval -0.03 to 0.02

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
White Wine
n=20 Participants
One serving (5 ounces) of white wine daily for 3 weeks
White Grape Juice
n=20 Participants
One serving (6 ounces) of white grape juice daily for 3 weeks
Blood Levels of Estrone Concentration
0.03 Log scale, pg/mL
Interval -0.33 to 0.39
-0.10 Log scale, pg/mL
Interval -0.45 to 0.26

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
White Wine
n=20 Participants
One serving (5 ounces) of white wine daily for 3 weeks
White Grape Juice
n=20 Participants
One serving (6 ounces) of white grape juice daily for 3 weeks
Blood Levels of Dehydroepiandrosterone Sulfate (DHEAS)
4.18 Log scale, ug/dL
Interval 3.88 to 4.49
4.08 Log scale, ug/dL
Interval 3.77 to 4.38

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
White Wine
n=20 Participants
One serving (5 ounces) of white wine daily for 3 weeks
White Grape Juice
n=20 Participants
One serving (6 ounces) of white grape juice daily for 3 weeks
Blood Levels of Testosterone
2.75 Log scale, ng/dL
Interval 2.3 to 3.2
2.63 Log scale, ng/dL
Interval 2.18 to 3.09

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
White Wine
n=20 Participants
One serving (5 ounces) of white wine daily for 3 weeks
White Grape Juice
n=20 Participants
One serving (6 ounces) of white grape juice daily for 3 weeks
Blood Levels of Sex Hormone Binding Globulin (SHBG)
3.87 Log scale, nmol/L
Interval 3.49 to 4.26
3.90 Log scale, nmol/L
Interval 3.51 to 4.28

Adverse Events

White Wine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

White Grape Juice

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kenneth J Mukamal

Beth Israel Deaconess Medical Center

Phone: 617-754-1401

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place