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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Nicotine Dependence, Other Tobacco Product, Bladder Cancer, Lung Cancer, Cancer of Head and Neck

Intervention / Treatment
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* Device: HALO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological diagnosis of lung, head & neck, or bladder cancer within the past 5 years. AJCC (American Joint Committee on Cancer) stages I-IV Daily Smoking (at least 10 cigarettes per day for 10 years) and breath CO (carbon monoxide) greater than or equal to 9 ppm Does not wish to quit smoking now (anyone wishing to quit smoking will be referred for smoking cessation counselling through the DHMC (Dartmouth Hitchcock Medical Center) program) May be receiving anti-cancer agents Age 18 or older Fluent in English; Patient must be capable and willing to provide informed written consent for study participation; Able to participate in study visits Exclusion Criteria: Cancer surgery planned in the next 9 weeks; Treatment with radiation planned for the next 9 weeks, Actively trying to quit smoking, or planning to in the next 30 days. (If a subject reports that they plan to quit smoking in the next 30 days, we will call them after the 30 days to see if they are still trying to quit.) Any use of e-cigarettes in the past 30 days, Pregnant or trying to get pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HALO G6<br>HALO cigalike model | Device: HALO<br>* HALO manufactures e-cigarettes which will be distributed to patients. Two products, the G6 and tank model will be used.<br>|
| Active Comparator: HALO Triton<br>HALO tank model | Device: HALO<br>* HALO manufactures e-cigarettes which will be distributed to patients. Two products, the G6 and tank model will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day | 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. | 12 Weeks | 
| Average Number of E-cigarettes Used Per Day | Average number of e-cigarettes used per day over the 12 week period | 12 Weeks |