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


N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer, Myocardial Infarction.

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of cigarettes smoked

Outcome Time Frame:

two months after event (cancer or myocardial infarction)

Safety Issue:

No

Principal Investigator

Carlo Cipolla, MD

Investigator Role:

Study Chair

Investigator Affiliation:

European Institute of Oncology

Authority:

Italy: Ethics Committee

Study ID:

IEO S617/211

NCT ID:

NCT01733706

Start Date:

June 2011

Completion Date:

December 2012

Related Keywords:

  • Cancer
  • Myocardial Infarction.
  • No Nicotine Electronic Cigarette
  • Antismoke intervention
  • Infarction
  • Myocardial Infarction

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