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OpenTrials
Completed

NCT Number: NCT02062255

Impact of COX2 on Sera Biomarkers From Obese Subjects

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

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Key information

Conditions

Breast Cancer Survivors Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Cancer Therapy and Research Center at UTHSCSA

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

Omega 3 FFA

Dietary Supplement

Primary outcomes

  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 outcomes

  1. BMI

    Time frame: 29 Days

    Correlation for body mass index impact on response to COX2 inhibition.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 13, 2014
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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