CLINICAL STUDY OF THE EFFECT OF COMBINED TREATMENT OF ASPIRIN AND ZILEUTON ON BIOMARKERS OF TOBACCO-RELATED CARCINOGENESIS IN CURRENT SMOKERS

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The proposed study shall assess the effects of daily aspirin 81 mg per day dose given along with zileuton (Zyflo-CR) 2 tablets x 600 mg each twice a day versus placebo for 3 months on selected smoking-related gene expression signature and three lung cancer-related signatures in the nasal epithelium of current smokers, and to evaluate any difference between both study arms. This study is an early step in larger effort to evaluate whether or not aspirin plus zileuton (Zyflo-CR) could be useful in prevention of lung cancer. The trial shall be performed at the University of Arizona, which shall be responsible for participant recruitment, patient care, data analysis, report preparation, and manuscript preparation. Boston University (Dr. A. Spira’s group), a collaborator on this study, shall be responsible for all gene signatures related analyses with Dr. Jun Young, Ph.D. from UC Davis, another study collaborator, being responsible for arachidonic acid (AA) metabolomics analyses.