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

NCT ID: NCT01796951

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-02-29

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.

Conditions

Tobacco Use Disorder; Smoking

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Celecoxib, aspirin, followed by aspirin/celecoxib

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

Group Type: EXPERIMENTAL

Aspirin 325 mg daily

Intervention Type: 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

Intervention Type: 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.

Interventions

Aspirin 325 mg daily

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.

Intervention Type: DRUG

Celecoxib 200 mg BID

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Philip Lammers

Hematology/Oncology Clinical Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John A Oates, MD

Role: STUDY_DIRECTOR

Vanderbilt University

Locations

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

VR5137

Identifier Type: -

Identifier Source: org_study_id