Substudy of Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (ESTxENDS Trial)- the Micronuclei Substudy of ESTxENDS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,246
- 试验地点
- 8
- 主要终点
- Frequency of buccal micronuclei_2
研究概览
简要总结
--> This is a substudy of the main ESTxENDS trial (NCT03589989). Micronuclei in buccal epithelial outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989.
Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer, e-cigarette or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking.
The micronucleus cytologic assay test was originally developed to screen for drug toxicity in bone marrow samples from mammals. The technique identifies micronuclei on smears obtained by oral cavity exfoliation and indicate genomic instability. Buccal MNs may predict cancer risk for the upper aerodigestive tract. The HUman MicroNucleus project on eXfoLiated buccal cells (HUMNXL) found MN counts gradually increased during the progression from normal mucosal to precancerous lesions to carcinoma. MN assessment discriminates between exposure to tobacco smoke in smokers and in non-smokers, and has been tested on a small number of ENDS users.
For the main ESTxENDS trial (NCT03589989), cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. All participants will be followed over a 24-month period. Measures of MN frequency will test the potential effect of ENDS use on cancer-related outcomes, in particular incident of mouth-, lung- and kidney- cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Statisticians and laboratory personnel will be blinded to group allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent as documented by signature
- •Persons aged 18 or older
- •Currently smoking 5 or more cigarettes a day for at least 12 months
- •Willing to try to quit smoking within the next 3 months,
- •Persons providing a valid phone number, a valid email address and/or a valid postal address.
排除标准
- •Known hypersensitivity or allergy to contents of the e-liquid Participation in another study with investigational drug within the 30 days preceding the baseline visit and during the present study where interactions are to be expected
- •Women who are pregnant or breast feeding
- •Intention to become pregnant during the course of the scheduled study intervention, i.e. within the first 6-months of the study
- •Persons having used ENDS regularly in the 3 months preceding the baseline visit
- •Persons having used nicotine replacement therapy (NRT) or other medications with demonstrated efficacy as an aid for smoking cessation such as varenicline or bupropion within the 3 months preceding the baseline visit
- •Persons who cannot attend the 6- month follow-up visit for any reason
- •Cannot understand instructions delivered in person or by phone, or otherwise unable to participate in study procedures
结局指标
主要结局
Frequency of buccal micronuclei_2
时间窗: 6 months post quit date
MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant.
Frequency of buccal micronuclei_1
时间窗: Baseline
MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant.
Frequency of buccal micronuclei_3
时间窗: 12 months post quit date
MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant.
Frequency of buccal micronuclei_4
时间窗: 24 months post quit date
MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant.
次要结局
- Change of frequency of buccal micronuclei(Change from baseline to 6,12, 24 months post quit date)