Ethanol Intoxication / Alcohol Drinking / Breast-pumping time · Interventional Study

Alcohol, Breast Cancer, and Metabolism

ClinicalTrials.gov · September 8, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a recruiting mechanistic study designed to measure alcohol and acetaldehyde concentrations in blood and breast milk from lactating women exposed to low-alcohol levels. The work aims to clarify local breast tissue metabolism of alcohol as a potential biological pathway relevant to breast cancer risk, but no results are yet available.

What was studied

Interventional, Randomized, Crossover, Open label, Basic Science purpose. Alcohol Drinking, Ethanol Intoxication, Breastfeeding; Female; age from 21 Years; to 45 Years; accepts healthy volunteers. Intervention: Arm 1: lactating women dose response; Arm 2: timing of pumping; Aim 3: non-lactating control women. n = 50. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a recruiting interventional study with no posted results, examining mechanistic pathways of alcohol metabolism in breast tissue via biomarker measurement in a small planned sample.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Blood alcohol concentrations (assessed at 2- 3 weeks); Milk alcohol concentration (assessed at 2- 3 weeks); Milk acetaldehyde (assessed at 1-3 weeks); Blood acetaldehyde (assessed at 1- 3 weeks)

DesignInterventional, Randomized, Crossover, Open label, Basic Science purpose

PopulationAlcohol Drinking, Ethanol Intoxication, Breastfeeding; Female; age from 21 Years; to 45 Years; accepts healthy volunteers

Sample size50

InterventionArm 1: lactating women dose response; Arm 2: timing of pumping; Aim 3: non-lactating control women

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned sample size50

Primary outcome measure 1Blood alcohol concentrations, 2–3 weeks

Primary outcome measure 2Milk alcohol concentration, 2–3 weeks

Primary outcome measure 3Milk acetaldehyde, 1–3 weeks

Primary outcome measure 4Blood acetaldehyde, 1–3 weeks

Caveats

This is a registry record only; no results are posted and the study is actively recruiting.
No comparator group, control exposure, or blinding strategy is described.
No power calculation or sample size justification is provided.
Study does not measure clinical breast cancer outcomes; findings address mechanistic pathways only.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional design with paired blood and milk sampling; no phase designation given.

Directness

limited

Measures alcohol metabolite concentrations; does not assess clinical cancer outcomes or causality.

Consistency

insufficient

No results posted; no comparator studies cited in registry record.

Risk of bias

insufficient

No information on blinding, allocation concealment, or control procedures in registry.

Sample adequacy

limited

Planned enrollment 50 participants; no power calculation or justification stated.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07779967). This is a study registration, not published results. Lead sponsor: University of Illinois at Urbana-Champaign. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Alcohol Drinking, Ethanol Intoxication, Breastfeeding. Interventions: OTHER: Low-alcohol level exposure; OTHER: Breast-pumping time. Primary outcome measures: Blood alcohol concentrations , 2- 3 weeks; Milk alcohol concentration , 2- 3 weeks; Milk acetaldehyde , 1-3 weeks; Blood acetaldehyde , 1- 3 weeks. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Ethanol IntoxicationAlcohol DrinkingBreast-pumping timeLow-alcohol level exposureNCT07779967BreastfeedingUniversity of Illinois at Urbana-Champaign