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

European Institute of Oncology

Status: Completed

Conditions: Myocardial Infarction; Cancer

Treatments: Device: No nicotine electronic cigarette; Other: Standard counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01733706

IEO S617/211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Standard counseling

Active Comparator group

Description:

a psychologist will provide standard counseling

Treatment:

Other: Standard counseling

No nicotine electronic cigarette

Experimental group

Description:

patients will receive standard counseling as well as an electronic cigarette

Treatment:

Other: Standard counseling

Device: No nicotine electronic cigarette