CancerNCT01733706
Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.
A study testing No nicotine electronic cigarette and Standard counseling in people with Cancer and Myocardial Infarction, run by European Institute of Oncology at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Myocardial Infarction
- What is being tested?
- No nicotine electronic cigarette and Standard counseling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesItaly
- Study dates
- Jun 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- patients with life expectancy less than 6 months;
- patients who have undertaken structured attempts to stop smoking over the past 3 months.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
European Institute of Oncology
Milan
Istituto Scientifico San Raffaele del Monte Tabor IRCCS
Milan
About this study
Official title: Evaluation of Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.
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.
Read the 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.
- Conditions
- Cancer, Myocardial Infarction
- Being tested
- No nicotine electronic cigarette, Standard counseling
- Keywords
- No Nicotine Electronic Cigarette, Antismoke intervention
- Medical subject headings
- Neoplasms, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No nicotine electronic cigaretteDevice
Also called e-cigarette "T-FUMOTM"
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.
Standard counselingOther
standard counseling
| Study group | Role | What they receive |
|---|---|---|
| Standard counseling | Active comparator | a psychologist will provide standard counseling Receives: Other: Standard counseling |
| No nicotine electronic cigarette | Experimental | patients will receive standard counseling as well as an electronic cigarette Receives: Device: No nicotine electronic cigarette; Other: Standard counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cigarettes smoked
Measured: two months after event (cancer or myocardial infarction)
psychological conditions
psychological conditions will be assessed by questionnaire
Measured: two months after event (cancer or myocardial infarction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startJun 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Cipolla, MD, Study chair, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733706
- Sponsor's protocol ID
- IEO S617/211
- Status last verified
- Dec 2015
- First submitted
- 21 Nov 2012
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.
- ClinicalTrials.gov ID
- NCT01733706
- Acronym / sponsor ID
- IEO S617/211
- Conditions
- Cancer, Myocardial Infarction
- Keywords
- No Nicotine Electronic Cigarette, Antismoke intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard counseling | Active comparator | Other: Standard counselinga psychologist will provide standard counseling |
| No nicotine electronic cigarette | Experimental | Device: No nicotine electronic cigarette, Other: Standard counselingpatients will receive standard counseling as well as an electronic cigarette |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- patients with life expectancy less than 6 months;
- patients who have undertaken structured attempts to stop smoking over the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No nicotine electronic cigaretteAlso: e-cigarette "T-FUMOTM"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. | Device | No nicotine electronic cigarette |
| Standard counselingstandard counseling | Other | No nicotine electronic cigarette, Standard counseling |
Primary outcome
Number of cigarettes smoked
Time frame: two months after event (cancer or myocardial infarction)
psychological conditions
Time frame: two months after event (cancer or myocardial infarction)
psychological conditions will be assessed by questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Cipolla, MD study chair
European Institute of Oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No nicotine electronic cigarette and Standard counseling in people with Cancer and Myocardial Infarction, run by European Institute of Oncology at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cigarettes smoked (time frame: two months after event (cancer or myocardial infarction)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.