Impact of COX2 on Sera Biomarkers From Obese Subjects

Study Overview
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Brief Summary
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Obesity promotes worse outcome for post-menopausal breast cancer patients.

Official Title
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A Phase 0, Investigator Initiated Study, Evaluating the Impact of COX2 Inhibition on Human Sera Biomarkers From Obese Subjects

Conditions
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Breast Cancer Survivors

Intervention / Treatment
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* Drug: Aspirin
* Dietary Supplement: Omega 3 FFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Post-menopausal as confirmed by medical history Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee Exclusion Criteria: Evidence of active cancer (patients with a prior history of malignancy are encouraged to participate, but due to cytokine levels associated with malignancy there must be no evidence of disease) Cachexia Active systemic illness (infection including viral illnesses such as Hepatitis and HIV) Chronic use of aspirin of omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days) Known hypersensitivity to aspirin and/or omega-3 fatty acids Actively receiving a physician-directed regimen of aspirin and/or receiving herapeutic/prophylactic anticoagulation Any aspirin or omega-3 free fatty acid supplementation within the last 14 days Subjects who are pregnant History of medical noncompliance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin<br>Twenty eight enteric coated 81mg Aspirin tablets will be dispensed for daily oral dosing, to be taken with a meal at the same time of day. | Drug: Aspirin<br> <br> |
| Active Comparator: Omega-3 Free Fatty Acids<br>Three hundred thirty-six gelatin coated 450 mg capsules containing approximately 180 mg of EPA and 135 mg of DHA will be dispensed. Patients are to take 12 capsules daily with meals, either once daily (12 capsules with one meal) or divided twice daily (e.g., six with breakfast and six with dinner). | Dietary Supplement: Omega 3 FFA<br> <br> |
| Active Comparator: Aspirin & Omega-3 FFAs<br>Aspirin (81 mg po daily) to be taken simultaneously with Omega-3 Free Fatty Acids (1500mg of docosahexaoic acid (DHA) and 2500mg eicosapentanoic acid (EPA) given daily. | Drug: Aspirin<br> <br> Dietary Supplement: Omega 3 FFA<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker levels | Blood levels of Prostaglandin E2, aromatase, pro-inflammatory cytokines, steroids, and lipids will be measured pre and post treatment. | 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | Correlation for body mass index impact on response to COX2 inhibition. | 29 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asprin, Omega-3 Free Fatty Acids, Obesity, COX-2 inhibitor