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

Primary Purpose

Cancer, Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
No nicotine electronic cigarette
Standard counseling
Sponsored by
European Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring No Nicotine Electronic Cigarette, Antismoke intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • European Institute of Oncology
  • Istituto Scientifico San Raffaele del Monte Tabor IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard counseling

No nicotine electronic cigarette

Arm Description

a psychologist will provide standard counseling

patients will receive standard counseling as well as an electronic cigarette

Outcomes

Primary Outcome Measures

Number of cigarettes smoked
psychological conditions
psychological conditions will be assessed by questionnaire

Secondary Outcome Measures

Full Information

First Posted
November 21, 2012
Last Updated
February 7, 2017
Sponsor
European Institute of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT01733706
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Institute of Oncology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Myocardial Infarction
Keywords
No Nicotine Electronic Cigarette, Antismoke intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard counseling
Arm Type
Active Comparator
Arm Description
a psychologist will provide standard counseling
Arm Title
No nicotine electronic cigarette
Arm Type
Experimental
Arm Description
patients will receive standard counseling as well as an electronic cigarette
Intervention Type
Device
Intervention Name(s)
No nicotine electronic cigarette
Other Intervention Name(s)
e-cigarette "T-FUMOTM"
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard counseling
Intervention Description
standard counseling
Primary Outcome Measure Information:
Title
Number of cigarettes smoked
Time Frame
two months after event (cancer or myocardial infarction)
Title
psychological conditions
Description
psychological conditions will be assessed by questionnaire
Time Frame
two months after event (cancer or myocardial infarction)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Cipolla, MD
Organizational Affiliation
European Institute of Oncology
Official's Role
Study Chair
Facility Information:
Facility Name
European Institute of Oncology
City
Milan
Country
Italy
Facility Name
Istituto Scientifico San Raffaele del Monte Tabor IRCCS
City
Milan
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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