Clinical trial · Interventional
Alcohol, Breast Cancer, and Metabolism
Localized Mammary Alcohol Metabolism as a Mechanism Linking Low-Level Alcohol Intake to Breast Cancer Risk
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alcohol Drinking | — | UNRESOLVED | — |
| Breastfeeding | — | UNRESOLVED | — |
| Ethanol Intoxication | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast-pumping time | Other | — | UNRESOLVED |
| Low-alcohol level exposure | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1: lactating women dose response
- description
- Lactating women who will drink \~0, 1 or 2 standard drinks of alcohol
- interventionNames
- Other: Low-alcohol level exposure
- type
- EXPERIMENTAL
- label
- Arm 2: timing of pumping
- description
- Lactating women will pump at two different times from alcohol drinking and at one of these times after placebo drinking
- interventionNames
- Other: Breast-pumping time
- type
- OTHER
- label
- Aim 3: non-lactating control women
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available