Impact of COX2 on Sera Biomarkers From Obese Subjects

NCT02062255 | Completed Early Phase 1 DMC

• 2 other identifiers: CTRC 13-0041HSC20130426H
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer Survivors

Keywords

Asprin; Omega-3 Free Fatty Acids; Obesity; COX-2 inhibitor

Outcome Measures

Primary Outcomes (1)

• Biomarker levels

  Blood levels of Prostaglandin E2, aromatase, pro-inflammatory cytokines, steroids, and lipids will be measured pre and post treatment.

  29 days

Secondary Outcomes (1)

• BMI

  29 Days

Study Arms (3)

Aspirin

ACTIVE COMPARATOR

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

Omega-3 Free Fatty Acids

ACTIVE COMPARATOR

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

Aspirin & Omega-3 FFAs

ACTIVE COMPARATOR

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; Dietary Supplement: Omega 3 FFA

Interventions

Aspirin DRUG

Aspirin; Aspirin & Omega-3 FFAs

Omega 3 FFA DIETARY_SUPPLEMENT

Aspirin & Omega-3 FFAs; Omega-3 Free Fatty Acids

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Cancer Therapy and Research Center at UTHSCSA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Andrew Brenner, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: February 13, 2014
• Study Start: October 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

US (1)