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Impact of COX2 on Sera Biomarkers From Obese Subjects

NCT ID: NCT02062255

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-04-30

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer Survivors

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

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).

Group Type ACTIVE_COMPARATOR

Omega 3 FFA

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Omega 3 FFA

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Aspirin

Intervention Type DRUG

Omega 3 FFA

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Andrew Brenner

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Brenner, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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Cancer Therapy and Research Center at UTHSCSA

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC20130426H

Identifier Type: OTHER

Identifier Source: secondary_id

CTRC 13-0041

Identifier Type: -

Identifier Source: org_study_id