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Impact of COX2 on Sera Biomarkers From Obese Subjects

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ClinicalTrials.gov Identifier: NCT02062255
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Andrew Brenner, The University of Texas Health Science Center at San Antonio

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

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Study Type : Interventional  (Clinical Trial)
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 : October 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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



Primary Outcome Measures :
  1. Biomarker levels [ Time Frame: 29 days ]
    Blood levels of Prostaglandin E2, aromatase, pro-inflammatory cytokines, steroids, and lipids will be measured pre and post treatment.


Secondary Outcome Measures :
  1. BMI [ Time Frame: 29 Days ]
    Correlation for body mass index impact on response to COX2 inhibition.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062255


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

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Responsible Party: Andrew Brenner, Principal Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02062255     History of Changes
Other Study ID Numbers: CTRC 13-0041
HSC20130426H ( Other Identifier: UTHSCSA IRB )
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Andrew Brenner, The University of Texas Health Science Center at San Antonio:
Asprin
Omega-3 Free Fatty Acids
Obesity
COX-2 inhibitor

Additional relevant MeSH terms:
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Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics