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Alcohol, Breast Cancer, and Metabolism

Localized Mammary Alcohol Metabolism as a Mechanism Linking Low-Level Alcohol Intake to Breast Cancer Risk

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07779967
Acronym
ABC-Met
Enrollment
50
Registered
2026-08-21
Start date
2026-09-03
Completion date
2032-03-01
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Breastfeeding, Ethanol Intoxication

Keywords

lactating, women, alcohol, ethanol, metabolism, breastmilk

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.

Detailed description

Alcohol consumption has been associated with an increased risk of female breast cancer, including at low levels of intake. The biological mechanisms underlying this association are not fully understood. One proposed pathway involves the metabolism of alcohol to alcohol-related compounds that may affect tissue biology. This study will examine alcohol metabolism in lactating women using paired blood and breast milk samples collected after low-level alcohol exposure. Human milk provides a non-invasive way to study biological processes occurring in the breast during lactation. By comparing alcohol-related measurements in milk and blood, and by considering the timing of sample collection relative to alcohol intake and breast pumping, the study will evaluate whether breast milk measurements provide information about local alcohol metabolism in the mammary gland that may not be reflected by blood measurements alone. The goal of this research is to improve understanding of how low-level alcohol exposure may influence biological pathways relevant to breast cancer risk. Findings from this study may help inform future research and support clearer risk communication regarding alcohol consumption and breast health.

Interventions

OTHERLow-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.

OTHERBreast-pumping time

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

Sponsors

University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Blood alcohol concentrations2- 3 weeksAlcohol concentrations in blood
Milk alcohol concentration2- 3 weeksConcentration of alcohol in breast milk
Milk acetaldehyde1-3 weeksConcentration of acetaldehyde in human milk
Blood acetaldehyde1- 3 weeksConcentration of acetaldehyde in blood

Countries

United States

Contacts

CONTACTMarta Y Pepino de Gruev, Ph D
ypepino@illinois.edu217-300-2374
PRINCIPAL_INVESTIGATORMarta Y Pepino de Gruev

University of Illinois at Urbana-Champaign

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026