Impact of COX2 on Sera Biomarkers From Obese Subjects

Early Phase 1

Completed

• Conditions: Breast Cancer Survivors
• Interventions: Drug: Aspirin; Dietary Supplement: Omega 3 FFA

• Registration Number: NCT02062255
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-13
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aspirin	Aspirin	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.
Omega-3 Free Fatty Acids	Omega 3 FFA	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).
Aspirin & Omega-3 FFAs	Omega 3 FFA	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.
Aspirin & Omega-3 FFAs	Aspirin	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.

Primary Outcome Measures

Name	Time	Method
Biomarker levels	29 days	Blood levels of Prostaglandin E2, aromatase, pro-inflammatory cytokines, steroids, and lipids will be measured pre and post treatment.

Secondary Outcome Measures

Name	Time	Method
BMI	29 Days	Correlation for body mass index impact on response to COX2 inhibition.

Trial Locations

Locations (1)

Cancer Therapy and Research Center at UTHSCSA; 🇺🇸 San Antonio, Texas, United States