Clinical trial NCT01733706: Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.
Official title: Evaluation of Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Myocardial Infarction
Keywords: No Nicotine Electronic Cigarette
Antismoke intervention
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the evaluation of early smoking reduction or cessation by means of no nicotine electronic cigarette added to standard counselling.

Detailed description: Cigarette smoking is one of the major health problems in the modern world for the impact on morbidity and mortality with devastating effects on cardio-cerebrovascular system and on tumor onset. After years of scientific doubts, today the scientific world agrees to define cigarette smoking not a "vice" but a disease.

The aim is to evaluate the effect of no nicotine electronic cigarette use in patients with cancer or myocardial infarction, smoking at least 10 cigarettes per day for at least 10 years, in addition to counselling activity performed by specialised dedicated medical doctors.

If patient is eligible for this trial, he will be enrolled in this trial and randomized. Randomization will be performed using a web-based procedure. Study participants will be randomized to electronic cigarette added to standard counselling or only standard counselling. A calendar will be given to the patient to remember the dates of visits or telephone counselling. After the first visit patient will be followed every ten days for the first two month through outpatient clinic visits and telephone counselling. After the first two months patient will return at institute for a last outpatient clinic visit at sixth month.

Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis of cancer and recently operated at European Institute of Oncology at Milan (Italy);
* patients with a diagnosis of hematology cancer treated at Foundation "San Raffaele del Monte Tabor" at Milan;
* patient with a recent occurrence of acute myocardial infarction from Monzino Cardiology Centre at Milan;
* age greater than 18 years;
* smokers stable for at least 10 cigarettes per day for at least 10 years.

Exclusion Criteria:

* patients with life expectancy less than 6 months;
* patients who have undertaken structured attempts to stop smoking over the past 3 months.

Primary outcomes:
measure: Number of cigarettes smoked
timeFrame: two months after event (cancer or myocardial infarction)
measure: psychological conditions
timeFrame: two months after event (cancer or myocardial infarction)
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
city: Milan
country: Italy
facility: Istituto Scientifico San Raffaele del Monte Tabor IRCCS
Study officials:
affiliation: European Institute of Oncology
name: Carlo Cipolla, MD
role: STUDY_CHAIR
References: