<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01733706</url>
  </required_header>
  <id_info>
    <org_study_id>IEO S617/211</org_study_id>
    <nct_id>NCT01733706</nct_id>
  </id_info>
  <brief_title>Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.</brief_title>
  <official_title>Evaluation of Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Institute of Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Institute of Oncology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is the evaluation of early smoking reduction or cessation by means of&#xD;
      no nicotine electronic cigarette added to standard counselling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cigarette smoking is one of the major health problems in the modern world for the impact on&#xD;
      morbidity and mortality with devastating effects on cardio-cerebrovascular system and on&#xD;
      tumor onset. After years of scientific doubts, today the scientific world agrees to define&#xD;
      cigarette smoking not a &quot;vice&quot; but a disease.&#xD;
&#xD;
      The aim is to evaluate the effect of no nicotine electronic cigarette use in patients with&#xD;
      cancer or myocardial infarction, smoking at least 10 cigarettes per day for at least 10&#xD;
      years, in addition to counselling activity performed by specialised dedicated medical&#xD;
      doctors.&#xD;
&#xD;
      If patient is eligible for this trial, he will be enrolled in this trial and randomized.&#xD;
      Randomization will be performed using a web-based procedure. Study participants will be&#xD;
      randomized to electronic cigarette added to standard counselling or only standard&#xD;
      counselling. A calendar will be given to the patient to remember the dates of visits or&#xD;
      telephone counselling. After the first visit patient will be followed every ten days for the&#xD;
      first two month through outpatient clinic visits and telephone counselling. After the first&#xD;
      two months patient will return at institute for a last outpatient clinic visit at sixth&#xD;
      month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cigarettes smoked</measure>
    <time_frame>two months after event (cancer or myocardial infarction)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>psychological conditions</measure>
    <time_frame>two months after event (cancer or myocardial infarction)</time_frame>
    <description>psychological conditions will be assessed by questionnaire</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Cancer</condition>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Standard counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>a psychologist will provide standard counseling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No nicotine electronic cigarette</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will receive standard counseling as well as an electronic cigarette</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>No nicotine electronic cigarette</intervention_name>
    <description>The e-cigarette &quot;T-FUMOTM&quot; 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.</description>
    <arm_group_label>No nicotine electronic cigarette</arm_group_label>
    <other_name>e-cigarette &quot;T-FUMOTM&quot;</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard counseling</intervention_name>
    <description>standard counseling</description>
    <arm_group_label>No nicotine electronic cigarette</arm_group_label>
    <arm_group_label>Standard counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with a diagnosis of cancer and recently operated at European Institute of&#xD;
             Oncology at Milan (Italy);&#xD;
&#xD;
          -  patients with a diagnosis of hematology cancer treated at Foundation &quot;San Raffaele del&#xD;
             Monte Tabor&quot; at Milan;&#xD;
&#xD;
          -  patient with a recent occurrence of acute myocardial infarction from Monzino&#xD;
             Cardiology Centre at Milan;&#xD;
&#xD;
          -  age greater than 18 years;&#xD;
&#xD;
          -  smokers stable for at least 10 cigarettes per day for at least 10 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with life expectancy less than 6 months;&#xD;
&#xD;
          -  patients who have undertaken structured attempts to stop smoking over the past 3&#xD;
             months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlo Cipolla, MD</last_name>
    <role>Study Chair</role>
    <affiliation>European Institute of Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>European Institute of Oncology</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Scientifico San Raffaele del Monte Tabor IRCCS</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>February 7, 2017</last_update_submitted>
  <last_update_submitted_qc>February 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>No Nicotine Electronic Cigarette</keyword>
  <keyword>Antismoke intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01733706
org study id: IEO S617/211
nct id: NCT01733706
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of cigarettes smoked
time frame: two months after event (cancer or myocardial infarction)
measure: psychological conditions
time frame: two months after event (cancer or myocardial infarction)
description: psychological conditions will be assessed by questionnaire
arm group label: Standard counseling
arm group type: Active Comparator
description: a psychologist will provide standard counseling
arm group label: No nicotine electronic cigarette
arm group type: Experimental
description: patients will receive standard counseling as well as an electronic cigarette
intervention type: Device
intervention name: No nicotine electronic cigarette
description: 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.
arm group label: No nicotine electronic cigarette
other name: e-cigarette "T-FUMOTM"
intervention type: Other
intervention name: Standard counseling
description: standard counseling
arm group label: No nicotine electronic cigarette
arm group label: Standard counseling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carlo Cipolla, MD
role: Study Chair
affiliation: European Institute of Oncology
facility: 
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Nicotine