Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers
- Conditions
- Tobacco Use DisorderSmoking
- Interventions
- Registration Number
- NCT01796951
- Lead Sponsor
- Vanderbilt University
- Brief Summary
Regular aspirin use has been associated with a reduction in the development of a number of different malignancies including lung cancer. The mechanism of aspirin's cancer prevention is not known. This study will evaluate whether once daily aspirin use can reduce the production of a protein named prostaglandin E2 (PGE-2), which is known to promote cancer. Specifically, this study will evaluate if aspirin can inhibit the production of PGE-2 by blocking an enzyme named cycloxygenase-2 (COX-2). To accomplish these goals, participants will take either aspirin 325 mg daily, celecoxib 200 mg twice daily, or the combination of both during various days of this 16-day study. Urine be collected to evaluate for PGE-2 production at 4 timepoints in this 16-day study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
- Male gender
- Age ≥35
- Current smoker of at least 10 cigarettes per day with history of ≥10 pack-years (py)
- Former smoker, quit no more than 15 years ago with a history of at least 25 py
- Ability to comply with the design of the study
- Capacity to freeze urine sample at participant's residence if this participant desires to store the urine specimens in this manner
- Baseline urine PGE-M > 13 ng/mg creatinine
- Serum thromboxane > 150 μg/L
- History of aspirin use 1-14 days prior to screening
- NSAID (ibuprofen, naprosyn, meloxicam, etc) use 1-7 days prior to screening
- Inhaled glucocorticoid use 1-7 days prior to screening
- Systemic glucocorticoid use 1-14 days prior to screening
- History of peptic ulcer disease
- Current or recent clinically significant bleeding
- Allergy, intolerance or contraindication to aspirin or NSAID use
- Thrombocytopenia (platelet count < 100,000) in 30 days prior to screening visit
- Severe hepatic insufficiency
- GFR < 30 mL/min/1.73 m2 in 30 days prior to screening visit
- History of aspirin or celecoxib allergy
- Elevated INR (>1.5) in 30 days prior to screening visit
- Current diagnosis of malignancy or history of non-skin malignancy in last 5 years
- Current use of systemic anticoagulants (e.g., warfarin (Coumadin), enoxaparin (Lovenox), Fondaparinux (Arixtra), dabigatran (Pradaxa))
- Diagnosis of COPD
- Intake of > 250 mg of fish oil supplementation daily
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Celecoxib, aspirin, followed by aspirin/celecoxib Aspirin 325 mg daily Celecoxib 200 mg twice daily x3 days, aspirin 325 mg daily x10 days, celecoxib 200 mb twice daily + aspirin 325 mg daily x 3 days Celecoxib, aspirin, followed by aspirin/celecoxib Celecoxib 200 mg BID Celecoxib 200 mg twice daily x3 days, aspirin 325 mg daily x10 days, celecoxib 200 mb twice daily + aspirin 325 mg daily x 3 days
- Primary Outcome Measures
Name Time Method Change in COX-2 dependent urinary PGE-M (ng/mg Cr) production after 16 days of aspirin treatment 16 days Baseline urinary PGE-2 metabolite (PGE-M) will be measured. Then after 3 days of COX-2 blockade with celecoxib, it will again be measured. Participants will then undergo 10 days of treatment with aspirin and urinary PGE-M will be measured. Finally, participants will be treated with combined aspirin and celecoxib for 3 days and urinary PGE-M will be measured one last time. Using these values, the degree of aspirin inhibition of COX-2 specific urinary PGE-M production can be calculated.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vanderbilt University
🇺🇸Nashville, Tennessee, United States