Clinical trial NCT01796951: Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers
Official title: Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Tobacco Use Disorder
Smoking
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 6
Sex: MALE
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in COX-2 dependent urinary PGE-M (ng/mg Cr) production after 16 days of aspirin treatment
timeFrame: 16 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: John A Oates, MD
role: STUDY_DIRECTOR
References: