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

Sponsor
European Institute of Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT01733706
Collaborator
(none)
75
Enrollment
2
Locations
2
Arms
54
Duration (Months)
37.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: No nicotine electronic cigarette
  • Other: Standard counseling
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard counseling

a psychologist will provide standard counseling

Other: Standard counseling
standard counseling
Experimental: No nicotine electronic cigarette

patients will receive standard counseling as well as an electronic cigarette

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 Names:
  • e-cigarette "T-FUMOTM"

    • Other: Standard counseling
    standard counseling

    Outcome Measures

    Primary Outcome Measures

    1. Number of cigarettes smoked [two months after event (cancer or myocardial infarction)]

    2. psychological conditions [two months after event (cancer or myocardial infarction)]

      psychological conditions will be assessed by questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 European Institute of Oncology Milan Italy
    2 Istituto Scientifico San Raffaele del Monte Tabor IRCCS Milan Italy

    Sponsors and Collaborators

    • European Institute of Oncology

    Investigators

    • Study Chair: Carlo Cipolla, MD, European Institute of Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    European Institute of Oncology
    ClinicalTrials.gov Identifier:
    NCT01733706
    Other Study ID Numbers:
    • IEO S617/211
    First Posted:
    Nov 27, 2012
    Last Update Posted:
    Feb 9, 2017
    Last Verified:
    Dec 1, 2015
    Keywords provided by European Institute of Oncology
    No Nicotine Electronic Cigarette
    Antismoke intervention
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction
    Nicotine

    Study Results

    No Results Posted as of Feb 9, 2017