NCT02123849

Intermittent or Continuous Acetylsalicylic Acid and Gene Expression in the Nasal Tissue of Current Smokers

The Effect of Intermittent Versus Continuous Dose Aspirin (ASA) on Nasal Epithelium Gene Expression in Current Smokers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This randomized phase II trial studies the safety and effects of acetylsalicylic acid (aspirin) taken continuously or intermittently on gene expression in the nasal tissue of current smokers. Smokers are at increased risk of developing lung cancer. Acetylsalicylic acid may be useful in preventing lung cancer.

Detailed description

PRIMARY OBJECTIVES: I. To analyze the impact of a 12-week intervention of intermittent and continuous acetylsalicylic acid (ASA) on a smoking-related gene expression signature in the nasal epithelium of current smokers and to analyze any difference between the intermittent and continuous ASA interventions. SECONDARY OBJECTIVES: I. To determine whether the change in the smoking-related gene expression signature of nasal epithelium persists one week off agent intervention. II. To compare the change in urinary prostaglandin E metabolite (PGE-M) and leukotriene E (4) (LTE \[4\]) between the continuous and intermittent dosing arms and to determine whether the change persists one week off agent intervention. III. To analyze the impact of intermittent and continuous ASA on a three lung cancer-related gene signatures (an 80-gene signature, a phosphoinositide 3-kinase \[PI3K\] gene signature, and a nasal epithelium cancer signature) in the nasal epithelium and to analyze any difference between the intermittent and continuous ASA interventions. IV. To determine whether the change, if any, in the lung cancer-related gene expression signatures of nasal epithelium persists one week off agent intervention. V. To compare the safety in current smokers of 12 week exposure to continuous versus intermittent ASA. VI. To evaluate a gender effect in the modulatory effects of intermittent and continuous ASA on smoking-related gene expression signature. VII. To explore in a discovery-driven fashion the effect of ASA intervention on whole-genome gene expression. VIII. To analyze the impact of intermittent and continuous ASA on karyometric analysis of buccal cells and to analyze any difference between intermittent and continuous ASA interventions. OUTLINE: Participants are randomized to 1 of 2 treatment arms. ARM I (CONTINUOUS): Participants receive aspirin orally (PO) once daily (QD) for 12 weeks. ARM II (INTERMITTENT): Participants receive placebo PO QD during weeks 1, 3, 5, 7, 9, and 11 and aspirin PO QD during weeks 2, 4, 6, 8, 10, and 12. After completion of study treatment, participants are followed up for 2 weeks.

Conditions

• Lung Carcinoma
• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	Aspirin	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Placebo	Given PO

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-09-01
• Completion: 2018-02-01
• First posted: 2014-04-28
• Last updated: 2018-08-29
• Results posted: 2018-08-29

Locations

2 sites across 1 country: United States