Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Rare Diseases

Head and Neck Neoplasms

Lung Neoplasms

Urinary Bladder Neoplasms

Tobacco Use Disorder

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Chronic Graft Versus Host Disease

HALO manufactures e-cigarettes which will be distributed to patients. Two products, the G6 and tank model will be used.

HALO

James D Sargent, MD

This study will test feasibility, in smokers with lung, head \& neck, and bladder cancers, that examines the effect of e-cigarette substitution, on measures of smoking-related toxicity and medical outcomes. The aim of the study is to determine the appeal of e-cigarettes compared to regular combustible cigarettes.

The aim of the study is to determine the appeal of e-cigarettes compared to combustible cigarettes as measured by the degree to which patients succeed in reducing their cigarette consumption over the 9 weeks they are supplied with product, along with their consumption of e-cigarettes. We will measure past use of e-cigarettes and cigarettes at baseline, 3, 6, 9, and 12 weeks. We will also assess the effect of e-cigarette substitution on toxicity by measuring expired carbon monoxide and urine NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) , a carcinogenic metabolite of cigarette smoke.

Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers

Participants report of daily cigarette and e-cigarette use for the previous 7 days at each study time-point (baseline and 3, 6, 9, and 12 weeks post-baseline) will be averaged to create usual daily cigarette. Mixed-effects linear regression with a random effect at the participant level will be used to assess the association between usual cigarette use (dependent variable) and usually e-cigarette use (independent predictor) over the study period while accounting for the repeated measures within subject. The model will be fit using restricted maximum likelihood. Time will be included in the model as continuous and categorical, separately, and we assess for stability of the association between cigarette use and e-cigarette over time by including an interaction term between e-cigarette use and time in the model.

Average number of e-cigarettes used per day over the 12 week period

Dartmouth-Hitchcock Medical Center

Professor of Pediatric Oncology

Enrolled participants using the e-cigarette.

Ecigarette Use

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr James Sargent

We used a linear mixed model to estimate associations between cigarette smoking and that of e-cigarette smoking, week and their interactions. We also used the same model to estimate association between biomarkers such as NNAL, Nicotine, Cotinine, Hydro and Creatinine and CO level, week and their interactions.

Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day

Average Number of E-cigarettes Used Per Day

Overall Study

Spots Global Cancer Trial Database for nicotine dependence, other tobacco product