Intermittent or Continuous Acetylsalicylic Acid and Gene Expression in the Nasal Tissue of Current Smokers
Condition: Lung Carcinoma; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Aspirin; Laboratory Biomarker Analysis; Placebo
Intervention description: Given PO; Correlative studies; Given PO
Intervention MeSH terms: Aspirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female current tobacco smokers with >= 20 pack years of self-reported smoking
             exposure and an average use of >= 10 cigarettes/day

          -  Karnofsky >= 70%

          -  Leukocytes >= 3,000/microliter

          -  Absolute neutrophil count >= 1,500/microliter

          -  Hematocrit within normal institutional limits

          -  Platelets within normal institutional limits

          -  Total bilirubin =< 1.5 × institutional upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 1.5 × institutional ULN

          -  Creatinine =< the upper institutional limits

          -  Prothrombin time (PT)/partial thromboplastin time (PTT) within normal institutional
             limits

          -  Fertile subjects must use adequate contraception (abstinence, barrier methods, or
             birth control pills) prior to study entry and for the duration of study participation

          -  Participants may have a history of indeterminate pulmonary nodule(s) by chest imaging
             if nodule follow-up has been completed or the study procedures would not interfere
             with nodule follow-up

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  History of allergic reaction to aspirin or attributed to compounds of similar chemical
             or biologic composition to aspirin, including other nonsteroidal anti-inflammatory
             drugs (NSAIDs)

          -  Gastric intolerance attributable to ASA or NSAIDs

          -  History of gastric ulcer within the past 5 years (with or without bleeding)

          -  Use of ASA or NSAIDs for more than 5 days per month within 3 months of enrollment

          -  Not willing or are unable to refrain from use of any non-study ASA or NSAIDs during
             the study period

          -  Adult asthma

          -  Chronic, current or recent (within the past three months) use of leukotriene
             antagonists

          -  Require chronic anticoagulation or anti-platelet therapy

          -  History of bleeding disorder or hemorrhagic stroke

          -  Chronic, current or recent (within the past three months) use of glucocorticoids
             (systemic, topical and/or nasal sprays)

          -  History of chronic sinusitis or recent nasal polyps

          -  Not willing or are unable to limit alcohol consumption to =< 2 alcoholic beverages a
             day during the study period

          -  Pregnant or lactating women; breastfeeding should be discontinued if the mother is
             treated with aspirin; should a woman become pregnant or suspect she is pregnant while
             participating in this study, she should inform her study physician immediately

          -  Participants may not be receiving any other investigational agents

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Have a known history of inability to absorb an oral agent

          -  Invasive cancer within the past five years except non-melanoma skin cancer

          -  Urine cotinine level, if collected at screening, does not confirm active smoking
             status