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Completed

NCT Number: NCT01796951

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

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.

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Key information

Age range

35 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Vanderbilt University

Nashville, Tennessee, 37212, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Aspirin 325 mg daily

Drug

In this single-arm trial, participants will take celecoxib 200 mg BID for 5 doses, followed by aspirin 325 mg daily for 10 days, followed by combination of celecoxib 200 mg BID for 5 doses and aspirin 325 mg daily for 3 days.

Celecoxib 200 mg BID

Drug

In this single-arm trial, participants will take celecoxib 200 mg BID for 5 doses, followed by aspirin 325 mg daily for 10 days, followed by combination of celecoxib 200 mg BID for 5 doses and aspirin 325 mg daily for 3 days.

Primary outcomes

  1. Change in COX-2 dependent urinary PGE-M (ng/mg Cr) production after 16 days of aspirin treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 22, 2013
Registry last updated
Apr 4, 2017

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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