Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers

Vanderbilt University

Status and phase

Completed

Early Phase 1

Conditions

Tobacco Use Disorder

Smoking

Treatments

Drug: Celecoxib 200 mg BID

Drug: Aspirin 325 mg daily

Study type

Interventional

Funder types

Other

Identifiers

NCT01796951

VR5137

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

35 to 90 years old

Volunteers

Accepts Healthy Volunteers

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