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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733706
• Other study ID #: IEO S617/211
• Status: Completed
• Phase: N/A
• First received: November 21, 2012
• Last updated: February 7, 2017
• Start date: June 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Infarction
• Myocardial Infarction

Intervention

Device:
• No nicotine electronic cigarette
The e-cigarette "T-FUMOTM" is a no nicotine electronic cigarette specifically designed to inactivate the early effects of the cessation of cigarette smoking, such as the craving caused by psychological reasons. It's formed by a filter which contains distilled water and food flavorings, an atomizer and a battery. On the opposite end to the filter there is a diode that lights up during aspiration. During the suction is generated hot air which, in contact with the liquid of the filter, generates steam which simulates the smoke of a traditional cigarette. The smoker has the sensation of smoking, but he does not suck the carcinogenic substances in traditional cigarettes and he does not assimilate nicotine.

Other:
• Standard counseling
standard counseling

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan
Italy	Istituto Scientifico San Raffaele del Monte Tabor IRCCS	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cigarettes smoked		two months after event (cancer or myocardial infarction)
Primary	psychological conditions	psychological conditions will be assessed by questionnaire	two months after event (cancer or myocardial infarction)