Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.

Not Applicable

Completed

• Conditions: Myocardial Infarction; Cancer
• Interventions: Device: No nicotine electronic cigarette; Other: Standard counseling

• Registration Number: NCT01733706
• Lead Sponsor: European Institute of Oncology

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-27
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No nicotine electronic cigarette	No nicotine electronic cigarette	patients will receive standard counseling as well as an electronic cigarette
No nicotine electronic cigarette	Standard counseling	patients will receive standard counseling as well as an electronic cigarette
Standard counseling	Standard counseling	a psychologist will provide standard counseling

Primary Outcome Measures

Name	Time	Method
psychological conditions	two months after event (cancer or myocardial infarction)	psychological conditions will be assessed by questionnaire
Number of cigarettes smoked	two months after event (cancer or myocardial infarction)

Trial Locations

Locations (2)

European Institute of Oncology; 🇮🇹 Milan, Italy

Istituto Scientifico San Raffaele del Monte Tabor IRCCS; 🇮🇹 Milan, Italy