Phase 2 N=54 Randomized Double-blind Prevention

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

Lung Carcinoma · Tobacco Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02123849 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: Changes in Smoking-related Gene Expression Signature Score in Nasal Epithelium — -1.11; 1.39 gene expression signature score — p=0.04

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Aspirin (Drug); Laboratory Biomarker Analysis (Other); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Smoking-related Gene Expression Signature Score in Nasal Epithelium	-1.11; 1.39	0.04 sig
SECONDARY Changes in Urine Leukotriene E4 (LTE(4)) Levels	-6.89; -21.90	0.84
SECONDARY Changes in Urine Prostaglandin E2 Metabolite (PGE-M) Levels	-3.73; -5.59	0.61
SECONDARY Number of Participants Experiencing Possibly/Probably/Definitely-related Adverse Events	3; 4	1.00
SECONDARY Gender Effect on Smoking-related Gene Expression Signature Score	0.45; -0.72	0.42
SECONDARY Changes in Lung Cancer-related Gene Expression Signature Score in the Nasal Epithelium	-0.03; 0.04	0.97
SECONDARY Persistence of the Change in the Lung Cancer-related Gene Expression Signature Score in the Nasal Epithelium One Week Off Agent Intervention	-0.04; 0.02	0.97
SECONDARY Persistence of the Change in the Smoking-related Gene Expression Signature Score in the Nasal Epithelium One Week Off Agent Intervention	-1.95; -0.1	0.06
SECONDARY Whole-genome Gene Expression - Number of Canonical Pathways Differentially Expressed	301; 120	—
SECONDARY Change in Buccal Cells Via Karyometric Analysis	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02123849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.