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

NCT02123849 | Completed Phase 2 Results DMC

• 7 other identifiers: NCI-2014-01006N01-CN-2012-00031HHSN26120120003111300000502UAZ2013-01-01N01CN00031P30CA023074
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lung Carcinoma; Tobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

• Changes in Smoking-related Gene Expression Signature Score in Nasal Epithelium

  Change in nasal smoking-related gene expression signature score derived from prior research was compared between the two study arms. Prior research showed that a higher score was observed in never smokers compared to current smokers. An increased score implicated a more favorable intervention effect. There is no minimum or maximum score.

  Baseline to 12 weeks (End-of-Intervention)

Secondary Outcomes (9)

• Changes in Urine Leukotriene E4 (LTE(4)) Levels

  Baseline to 12 weeks (End-of-Intervention)

• Changes in Urine Prostaglandin E2 Metabolite (PGE-M) Levels

  Baseline to 12 weeks (End-of-Intervention)

• Number of Participants Experiencing Possibly/Probably/Definitely-related Adverse Events

  Up to 2 weeks post-treatment

• Gender Effect on Smoking-related Gene Expression Signature Score

  Baseline to 12 weeks (End-of-Intervention)

• Changes in Lung Cancer-related Gene Expression Signature Score in the Nasal Epithelium

  Baseline to 12 weeks (End-of-Intervention)

Study Arms (2)

Arm I (continuous aspirin)

EXPERIMENTAL

Participants receive aspirin PO QD for 12 weeks.

Drug: Aspirin; Other: Laboratory Biomarker Analysis

Arm II (intermittent aspirin)

EXPERIMENTAL

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.

Drug: Aspirin; Other: Laboratory Biomarker Analysis; Other: Placebo

Interventions

Aspirin DRUG

Given PO

Also known as: Acetylsalicylic Acid, ASA, Aspergum, Ecotrin, Empirin, Entericin, Extren, Measurin

Arm I (continuous aspirin); Arm II (intermittent aspirin)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (continuous aspirin); Arm II (intermittent aspirin)

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Arm II (intermittent aspirin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

The University of Arizona Medical Center-University Campus

Tucson, Arizona, 85724, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Tobacco Use Disorder

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Sherry Chow
• Organization: University of Arizona

schow@azcc.arizona.edu

5206263358

Study Officials

• Linda Garland

  The University of Arizona Medical Center-University Campus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: February 1, 2018
• Last Updated: August 29, 2018
• Results First Posted: August 29, 2018

Record last verified: 2018-07

Locations

US (2)