Clinical trial · Interventional
Impact of COX2 on Sera Biomarkers From Obese Subjects
A Phase 0, Investigator Initiated Study, Evaluating the Impact of COX2 Inhibition on Human Sera Biomarkers From Obese Subjects
NCT02062255CI-TRIAL-00024446completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Obesity promotes worse outcome for post-menopausal breast cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Survivors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin | Drug | Aspirin | ALIAS |
| Omega 3 FFA | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Aspirin
- description
- 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.
- interventionNames
- Drug: Aspirin
- type
- ACTIVE_COMPARATOR
- label
- Omega-3 Free Fatty Acids
- description
- 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).
- interventionNames
- Dietary Supplement: Omega 3 FFA
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.