Impact of COX2 on Sera Biomarkers From Obese Subjects

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Completed

CT.gov ID

NCT02062255

Collaborator

(none)

126

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Survivors	Drug: Aspirin Dietary Supplement: Omega 3 FFA	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Aspirin
Active Comparator: Omega-3 Free Fatty Acids 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
Active Comparator: Aspirin & Omega-3 FFAs 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

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Aspirin

Active Comparator: Omega-3 Free Fatty Acids

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

Active Comparator: Aspirin & Omega-3 FFAs

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

Outcome Measures

Primary Outcome Measures

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

BMI [29 Days]
Correlation for body mass index impact on response to COX2 inhibition.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Therapy and Research Center at UTHSCSA	San Antonio	Texas	United States	78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

Principal Investigator: Andrew Brenner, MD, The University of Texas Health Science Center at San Antonio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrew Brenner, Principal Investigator, The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier:

NCT02062255

Other Study ID Numbers:

CTRC 13-0041
HSC20130426H

First Posted:

Feb 13, 2014

Last Update Posted:

Oct 26, 2016

Last Verified:

Oct 1, 2016

Keywords provided by Andrew Brenner, Principal Investigator, The University of Texas Health Science Center at San Antonio

Asprin

Omega-3 Free Fatty Acids

Obesity

COX-2 inhibitor

Additional relevant MeSH terms:

Aspirin

Study Results

No Results Posted as of Oct 26, 2016