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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01733706
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
European Institute of Oncology

Tracking Information
First Submitted Date  ICMJE November 21, 2012
First Posted Date  ICMJE November 27, 2012
Last Update Posted Date February 9, 2017
Study Start Date  ICMJE June 2011
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2012)
  • Number of cigarettes smoked [ Time Frame: two months after event (cancer or myocardial infarction) ]
  • psychological conditions [ Time Frame: two months after event (cancer or myocardial infarction) ]
    psychological conditions will be assessed by questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.
Official Title  ICMJE Evaluation of Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Myocardial Infarction
Intervention  ICMJE
  • 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 Name: e-cigarette "T-FUMOTM"
  • Other: Standard counseling
    standard counseling
Study Arms  ICMJE
  • Active Comparator: Standard counseling
    a psychologist will provide standard counseling
    Intervention: Other: Standard counseling
  • Experimental: No nicotine electronic cigarette
    patients will receive standard counseling as well as an electronic cigarette
    Interventions:
    • Device: No nicotine electronic cigarette
    • Other: Standard counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2016)
75
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2012)
126
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01733706
Other Study ID Numbers  ICMJE IEO S617/211
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Institute of Oncology
Study Sponsor  ICMJE European Institute of Oncology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Carlo Cipolla, MD European Institute of Oncology
PRS Account European Institute of Oncology
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP