Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
HALO G6
HALO cigalike model
干预措施: HALO (Device)
HALO Triton
HALO tank model
干预措施: HALO (Device)
结局指标
主要结局
Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day
时间窗: 12 Weeks
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
时间窗: 12 Weeks
Average number of e-cigarettes used per day over the 12 week period
次要结局
未报告次要终点
研究者
James D. Sargent
Professor of Pediatric Oncology
Dartmouth-Hitchcock Medical Center