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临床试验/NCT01733706
NCT01733706已完成不适用

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

European Institute of Oncology2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2011年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
2
主要终点
Number of cigarettes smoked

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • patients with life expectancy less than 6 months;
  • patients who have undertaken structured attempts to stop smoking over the past 3 months.

结局指标

主要结局

Number of cigarettes smoked

时间窗: two months after event (cancer or myocardial infarction)

psychological conditions

时间窗: two months after event (cancer or myocardial infarction)

psychological conditions will be assessed by questionnaire

次要结局

未报告次要终点

研究者

发起方
European Institute of Oncology
申办方类型
Other
责任方
Sponsor

研究点 (2)

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