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

Study 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.

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Key things to know

Main goalPrevention

This describes the study’s primary purpose.

What is being studiedAspirin and Laboratory Biomarker Analysis

Plus 1 other study approaches.

Who it may be forLung Carcinoma · Tobacco Use Disorder

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 29, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?National Cancer Institute (NCI)

Study sponsor

Study overview

What this study is about

Purpose: Prevention
Study type: Interventional
Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
Interventions being studied: Drug: Aspirin; Other: Laboratory Biomarker Analysis; Other: Placebo

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

The University of Arizona Medical Center-University CampusTucson, Arizona
Boston University School of MedicineBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 29, 2018. Always confirm current availability with the study team.

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