Benefits of Tobacco Free Cigarette Among Heavy Smokers Undergoing a Lung Cancer Screening Program: a Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Milan
- Enrollment
- 210
- Locations
- 2
- Primary Endpoint
- Change in pulmonary health (dry cough, breath shortness, mouth irritation) index
Study Overview
Brief Summary
Background. Smoking is considered a global public health problem. For this reason, the smoking dependence was called by experts as a global epidemic.
Over the past three years, this electronic devices (Tobacco Free Cigarettes, or TFC) has been an important expansion in many countries. Nevertheless, there is poor evidence that TFC are beneficial for smoking cessation. In particular, even though it has been proved that the nicotine replacement devices helps many individuals to give up smoking and to tolerate the withdrawal symptoms, it is still unclear their long-term effect. Hence, it must be tested its contribution in tobacco reduction. This protocol in particularly innovative, since it aims to test the efficacy of electronic devices in a screening program (the lung cancer prevention program COSMOS II at the IEO), where tobacco reduction is strictly needed in order to lower individual's risk.
Methods and Design. This experimental protocol has been designed with the main aim to investigate the role of Tobacco Free Cigarettes (TFC), also called e-cigarettes, in helping smokers to improve their lung health and to quit or reduce tobacco consuming. In particular, the investigators aim at investigating clinical (physical symptoms, with particular focus on breathing quality and difficulties), the behavioral (number of tobacco cigarettes smoked), and psychological (wellbeing, mood and quality of life) effects of shifting to TFC.
The investigators will also analyze, as a secondary aim, the psychological and lifestyle component of smokers involved in order to fine correlation data that might be used to compute a predictor index able to suggest the probability of success, with respect to the reduction of tobacco consuming, of the use of a TFC and to maintain the abstinence. The study will be organized as a nested randomized controlled study with two arms: one experimental group and one control group. The study will be nested in the screening program for lung cancer, where subjects will be recruited.
All subjects will be entered in a psycho-cognitive low-intensity counseling program (6 months), but in the experimental group a TFC (with or without nicotine) will be used as replacement device for three months, while in the control group only low-intensity counseling will be provided. Furthermore, a low-cost non-invasive electronic device (the FitBit activity tracker) will be used in order to monitor behavioral (lifestyle), sleep quality and physical activities.
Detailed Description
The World Health Organization has been estimated that cigarette smoking will claim the lives of 500 million people alive today and as many as one billion people in the 21st century. Even though clinical therapy for smoking cessation have showed efficacy, long-time abstinence rate is low yet.
Tobacco Free Cigarettes (TFC, also known as electronic cigarettes) are battery-operated devices designed to vaporize a liquid solution of propylene glycol and/or vegetable glycerin in which nicotine or other aromas may be dissolved.
The worth of these tools is that it reduces the risk for smoking related diseases. If the use of the TFC in heavy smokers favor a reduction of the cancers' risk, the role in antismoking program has not completed cleared yet. the World Health Organization (WHO) and the US Food and Drug Administration (FDA) have promoted the launch of research on this field.
In a prospective 6-month study, TFCs were shown to substantially decrease tobacco cigarettes consumption without causing significant side effects. The study showed that declines in cig/day use and expired carbon monoxide (CO) levels were observed at each study visits in all three study groups, with no consistent differences among study groups. Furthermore, rapid improvement of breathing symptoms were recorded.
However, tobacco cigarettes consumption after 1 year were reported only in about 10% of participants. This is probably due to the fact that the research was targeted to smokers non intended to quit. We argue that in motivated smokers much better result might be achieved.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects involved in the early lung cancer detection program (Cosmos II) of the European Institute of Oncology.
- •Subjects should have smoked at least 10 cigarettes a day for the past 10 years
- •Subjects that would like to reduce tobacco smoking but are not willing to be followed by a smoking center
- •To have an high motivational scoring (more than 10 points to the motivation questionnaire);
- •Signed informed consent
Exclusion Criteria
- •symptomatic severe cardiovascular disease
- •symptomatic severe respiratory disease
- •regular psychotropic medication use
- •current or past history of alcohol abuse
- •use of smokeless tobacco or nicotine replacement therapy
- •pregnancy or breastfeeding.
- •Subjects involved in other antismoking program in the current year.
Arms & Interventions
Nicotine
Smoking cessation program TFC and activity tracker. Three months low intensity counselling at distance program. Subject will also undergo a 3-months TFC (with nicotine) program; subjects smoking behaviour and wellbeing will be assessed at baseline, at 6 months and at one year. Life style will be evaluted by the use of an activity tracker and ad-hoc items.
Intervention: Smoking cessation program TFC and activity tracker (Behavioral)
Nicotine-free
Smoking cessation program TFC-free and activity tracker. Three months low intensity counselling at distance program. Subject will also undergo a 3-months TFC (nicotine-free) program; subjects smoking behaviour and wellbeing will be assessed at baseline, at 6 months and at one year. Life style will be evaluted by the use of an activity trackerand ad-hoc items.
Intervention: Smoking cessation program TFC-free and activity tracker (Behavioral)
No-cig
Smoking cessation program and activity tracker. Three months low intensity counselling at distance program;subjects smoking behaviour and wellbeing will be assessed at baseline, at 6 months and at one year. Life style will be evaluted by the use of an activity tracker and ad-hoc items.
Intervention: Smoking cessation program and activity tracker (Behavioral)
Outcomes
Primary Outcomes
Change in pulmonary health (dry cough, breath shortness, mouth irritation) index
Time Frame: baseline, 6 months, 12 months
To evaluate the impact of a three months TFC program to reduce smoking-related respiratory symptoms (dry cough, breath shortness, mouth irritation and catarrh) as consequence of a reduced tobacco cigarettes consumption among a CT screening population.
Secondary Outcomes
- Change in psychological wellbeing (had scale)(baseline, 6 months, 12 months)
- Change in expired air carbon monoxide concentration(baseline, 6 months, 12 months)
- Change in values of the cough related quality of life questionnaire.(baseline, 6 months, 12 months)
- Change in number of daily cigarettes(baseline, 6 months, 12 months)
- Change in lifstyle as measure by ad-hoc questionnaires(baseline, 6 months, 12 months)
- Change in daily activity (mean number of daily steps)(baseline, 6 months, 12 months)
Investigators
claudio lucchiari
Prof
University of Milan