Impact of COX2 on Sera Biomarkers From Obese Subjects

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Breast Cancer Survivors

Treatments: Drug: Aspirin; Dietary Supplement: Omega 3 FFA

Study type: Interventional

Funder types: Other

Identifiers

NCT02062255

HSC20130426H (Other Identifier)

CTRC 13-0041

Details and patient eligibility

About

Obesity promotes worse outcome for post-menopausal breast cancer patients.

Enrollment: 126 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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126 participants in 3 patient groups

Aspirin

Active Comparator group

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.

Treatment:

Drug: Aspirin

Omega-3 Free Fatty Acids

Active Comparator group

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).

Treatment:

Dietary Supplement: Omega 3 FFA

Aspirin & Omega-3 FFAs

Active Comparator group

Description:

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.

Treatment:

Drug: Aspirin

Dietary Supplement: Omega 3 FFA