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

• ClinicalTrials.gov Identifier: NCT01733706
• Recruitment Status: Completed
• First Posted: November 27, 2012
• Last Update Posted: February 9, 2017
• Sponsor: European Institute of Oncology
• Information provided by (Responsible Party): European Institute of Oncology

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
Cancer; Myocardial Infarction	Device: No nicotine electronic cigarette; Other: Standard counseling	Not Applicable

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 (Clinical Trial)
• 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: June 2011
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 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 Name: e-cigarette "T-FUMOTM"; Other: Standard counseling; standard counseling

Outcome Measures

Primary Outcome Measures :

1. Number of cigarettes smoked [ Time Frame: two months after event (cancer or myocardial infarction) ]
2. psychological conditions [ Time Frame: two months after event (cancer or myocardial infarction) ]
   psychological conditions will be assessed by questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Italy

European Institute of Oncology

Milan, Italy

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

More Information

• Responsible Party: European Institute of Oncology
• ClinicalTrials.gov Identifier: NCT01733706
• Other Study ID Numbers: IEO S617/211
• First Posted: November 27, 2012
• Last Update Posted: February 9, 2017
• Last Verified: December 2015

Keywords provided by European Institute of Oncology:

No Nicotine Electronic Cigarette; Antismoke intervention

Additional relevant MeSH terms:

Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action