N/A
N=19
Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers
Nicotine Dependence, Other Tobacco Product · Bladder Cancer · Lung Cancer · Cancer of Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT02648178 ↗Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Sep 2019
Primary outcome: Primary: Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day — 4.37 number of Daily Cigarettes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HALO (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day |
4.37 | — |
| PRIMARY Average Number of E-cigarettes Used Per Day |
5.04 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02648178). 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.