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Impact of COX2 on Sera Biomarkers From Obese Subjects

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02062255
Enrollment
126
Registered
2014-02-13
Start date
2013-10-31
Completion date
2016-04-30
Last updated
2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Survivors

Keywords

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

Brief summary

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

Interventions

DRUGAspirin
DIETARY_SUPPLEMENTOmega 3 FFA

Sponsors

The University of Texas Health Science Center at San Antonio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Biomarker levels29 daysBlood levels of Prostaglandin E2, aromatase, pro-inflammatory cytokines, steroids, and lipids will be measured pre and post treatment.

Secondary

MeasureTime frameDescription
BMI29 DaysCorrelation for body mass index impact on response to COX2 inhibition.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026