Clinical trial NCT02648178: Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers
Official title: Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence, Other Tobacco Product
Bladder Cancer
Lung Cancer
Cancer of Head and Neck
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Histological or cytological diagnosis of lung, head \& neck, or bladder cancer within the past 5 years.
2. AJCC (American Joint Committee on Cancer) stages I-IV
3. Daily Smoking (at least 10 cigarettes per day for 10 years) and breath CO (carbon monoxide) greater than or equal to 9 ppm
4. 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)
5. May be receiving anti-cancer agents
6. Age 18 or older
7. Fluent in English;
8. Patient must be capable and willing to provide informed written consent for study participation;
9. Able to participate in study visits

Exclusion Criteria:

1. Cancer surgery planned in the next 9 weeks;
2. Treatment with radiation planned for the next 9 weeks,
3. 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.)
4. Any use of e-cigarettes in the past 30 days,
5. Pregnant or trying to get pregnant.

Primary outcomes:
measure: Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day
timeFrame: 12 Weeks
measure: Average Number of E-cigarettes Used Per Day
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: James D Sargent, MD
role: PRINCIPAL_INVESTIGATOR
References: