Recruiting

Alcohol & Breast Cancer

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT07779967

Conditions

Alcohol Drinking

Ethanol Intoxication

Breastfeeding

Eligibility Criteria

Sex: Female

Age: 21 - 45

Healthy Volunteers: Accepted

Interventions

Low-alcohol level exposure

Breast-pumping time

Study Details

Brief summary:

Alcohol consumption, even at low levels, has been associated with increased breast cancer risk, but the biological mechanisms underlying this relationship remain unclear. This study will examine whether breast tissue may locally metabolize alcohol by measuring alcohol-related compounds in paired blood and breast milk samples from lactating women. The findings may help clarify alcohol-related biological pathways relevant to breast cancer risk and improve risk communication.

Conditions

Alcohol Drinking

Ethanol Intoxication

Breastfeeding

Study ID

NCT07779967

Start date

Sep 3, 2026

Status verified date

Sep, 2026

Completion date

Mar 1, 2032

Anticipated

Primary completion date

Jul 13, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

All aims

-Drink alcohol (at least one alcoholic drink during lactation of a lactating female)

For aims 1 and 2

  • Nursing a 2- to 5-month-old infant
  • Experienced with a breast pump

Exclusion Criteria:

  • Pregnant
  • Lifetime history of alcohol dependence
  • Drink more than 3 standard drinks per day or more than 7 standard drinks per week in the month previous to enrollment
  • Current regular use of drugs with addiction potential (other than alcohol)
  • Use of medications known to interact with alcohol metabolism
  • Current smoking
  • Anemia
  • Diabetes
  • Liver disease

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Arm 1: lactating women dose response

Lactating women who will drink \~0, 1 or 2 standard drinks of alcohol

experimental: Arm 2: timing of pumping

Lactating women will pump at two different times from alcohol drinking and at one of these times after placebo drinking

other: Aim 3: non-lactating control women

Non-lactating women of similar age, BMI, and alcohol consumption characteristics will drink a similar dose of alcohol as lactating women for the assessment of systemic alcohol-related measurements. This group will serve as a comparison group for interpreting alcohol-related measurements in lactating participants.

Interventions

Low-alcohol level exposure

Participants will consume a protocol-specified low-level alcohol exposure under study conditions. The assigned dose and biospecimen collection procedures will vary by study group.

Breast-pumping time

Breast pumping before or after drinking \~ 1 standard drink or placebo drink

Primary outcome measure

  • Blood alcohol concentrations [ Time Frame: 2- 3 weeks ]
  • Milk alcohol concentration [ Time Frame: 2- 3 weeks ]
  • Milk acetaldehyde [ Time Frame: 1-3 weeks ]
  • Blood acetaldehyde [ Time Frame: 1- 3 weeks ]

Central Contacts and Locations

Central contacts

Marta Y Pepino de Gruev, Ph D

217-300-2374ypepino@illinois.edu

Locations

Bevier Hall; University of Illinois at Urbana Champaign

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Marta

217-300-2374ypepino@illinois.edu

Eva Hu, BS

217-300-4709swhu2@illinois.edu

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • lactating
  • women
  • alcohol
  • ethanol
  • metabolism
  • breastmilk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2026-09-08.