Alcohol, Breast Cancer, and Metabolism

NCT07779967 | Recruiting DMC

• 1 other identifier: 26-0686
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

lactating; women; alcohol; ethanol; metabolism; breastmilk

Outcome Measures

Primary Outcomes (4)

• Blood alcohol concentrations

  Alcohol concentrations in blood

  2- 3 weeks

• Milk alcohol concentration

  Concentration of alcohol in breast milk

  2- 3 weeks

• Milk acetaldehyde

  Concentration of acetaldehyde in human milk

  1-3 weeks

• Blood acetaldehyde

  Concentration of acetaldehyde in blood

  1- 3 weeks

Study Arms (3)

Arm 1: lactating women dose response

EXPERIMENTAL

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

Other: Low-alcohol level exposure

Arm 2: timing of pumping

EXPERIMENTAL

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

Other: Breast-pumping time

Aim 3: non-lactating control women

OTHER

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.

Other: Low-alcohol level exposure

Interventions

Low-alcohol level exposure OTHER

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.

Aim 3: non-lactating control women; Arm 1: lactating women dose response

Breast-pumping time OTHER

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

Arm 2: timing of pumping

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

Bevier Hall; University of Illinois at Urbana Champaign

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking; Breast Feeding

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Feeding Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Marta Y Pepino de Gruev

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Y Pepino de Gruev, Ph D

CONTACT

217-300-2374; ypepino@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Aim 1: lactating women will be assessed with two doses of alcohol ; Aim 2, lactating women will be assessed with one dose of alcohol with varying breast pumping times; Aim 3 non-lactating women will be assessed with one dose of alcohol with varying blood sample sites (arterialized vs vein).

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start: September 3, 2026
• Primary Completion (Estimated): July 13, 2031
• Study Completion (Estimated): March 1, 2032
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: From the end of the grant until NIAAA Da allows it.
• Access Criteria: The data will be shared with NIAAA DA and they will determine the protocol to access.

Locations

US (1)