Alcohol, Breast Cancer, and Metabolism
Purpose
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
Eligibility
- Eligible Ages
- Between 21 Years and 45 Years
- Eligible Sex
- Female
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- 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).
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm 1: lactating women dose response |
Lactating women who will drink ~0, 1 or 2 standard drinks of alcohol |
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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 |
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|
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. |
|
Recruiting Locations
Urbana, Illinois 61801
More Details
- Status
- Recruiting
- Sponsor
- University of Illinois at Urbana-Champaign
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.