Cancer of the Upper Aero-digestive TractNCT00825448
Alcohol Addiction and Otorhinolaryngology Cancer
A study testing Hospitalization for a week in people with Cancer of the Upper Aero-digestive Tract and Alcoholism, run by Department of Clinical Research and Innovation at 1 site in France.
Trial summary
The aim of the study is to compare the hospitalisation period in ORL surgery for two groups of patients. One of them will be treated for alcohol addiction to weaning them before the surgery ORL. The other group will be treated with usual methods. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer of the Upper Aero-digestive Tract, Alcoholism
- What is being tested?
- Hospitalization for a week
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Jan 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years, male or female
- Clinically and histologically verified ORL cancer required surgery
- Patient with alcohol addiction
- Men must consume 21 glasses of wine a week
- Women must consume 14 glasses of wine a week
- CPAM affiliation
- Able to give written informed consent to participate in the study
Who cannot join
- Inability to give informed consent
- Patient with regulatory authority or private patient freedom
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Fédération des maladies de l'appareil digestif - Hôpital ARCHET
Nice, 06202
Eve Gelsi, MD, + 33 4 92 03 60 18, gelsi.e@chu-nice.fr
Albert Tran, PhD, + 33 4 92 03 62 32, tran.a@chu-nice.fr
About this study
Official title: Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer
The aim of the study is to compare the hospitalisation period in ORL surgery for two groups of patients. One of them will be treated for alcohol addiction to weaning them before the surgery ORL. The other group will be treated with usual methods.
Read the detailed description
Alcohol, associated or not associated with tobacco, is known to increase the incidence of ORL cancer. So, in fact many patients perform their ORL surgery operation in spite of their alcohol addiction.
Many studies showed that a post surgery weaning syndrome increases morbidity and mortality.
So our study will focuses on the benefits of pre surgery medical weaning program.
The protocol is an open randomised, prospective study. The patient will be divided in two groups. In one hand, the first group is designed as "treated" will get alcohol weaning in the hospital alcohol department. The patient will be hospitalized during one week before the ORL surgery.
During this hospitalisation, the patient will receive medicinal treatment, medical follow-up and psychological counselling.
In the other hand, the second group designed as "control group" will be hospitalized directly in ORL surgery department. The patient will be received a treatment for alcohol weaning according to their symptom.
After their hospitalisation, the treated group will be followed-up regularly for their alcohol addiction either in support group or in individual counselling. The control group will be followed-up with the usual method in the ORL surgery department.
The expected result is to improve the care for patients with alcohol addiction and who must have an ORL surgery reducing the hospitalisation duration, the level of post operative complication and increasing the abstinence level. 115 patients will be included in this study.
- Being tested
- Hospitalization for a week
- Keywords
- alcohol addiction
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospitalization for a weekProcedure or surgery
Patient in hospital a week before the date of surgery for the treatment of their addiction to alcohol (alcohol weaning)
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | patient in hospital a week before the date of surgery for the treatment of his addiction alcohol Receives: Procedure: Hospitalization for a week |
| 1 | No intervention | no treatment of his addiction alcohol during a week before the date of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study will be to compare the duration of post surgery hospitalisation between the patients who benefit with an alcohol weaning and the patient treated with usual methods.
time between the surgery and the exit of the hospital
Measured: two weeks
Secondary outcomes (1)
The secondary objective is to note: the presence of weaning syndrome, the diagnostic of Delirium tremens, the occurrence of post surgeries complications.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Upper Aero-digestive TractStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Clinical Research and Innovation
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor-investigator, Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
- Investigators
- Albert TRAN, PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825448
- Sponsor's protocol ID
- 2008-A00634-51
- Status last verified
- Dec 2011
- First submitted
- 20 Jan 2009
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer
- ClinicalTrials.gov ID
- NCT00825448
- Acronym / sponsor ID
- 2008-A00634-51
- Keywords
- alcohol addiction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Department of Clinical Research and InnovationUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- Jan 2009
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 21 Jan 2009 (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 the study is to compare the hospitalisation period in ORL surgery for two groups of patients. One of them will be treated for alcohol addiction to weaning them before the surgery ORL. The other group will be treated with usual methods.
Detailed description
Alcohol, associated or not associated with tobacco, is known to increase the incidence of ORL cancer. So, in fact many patients perform their ORL surgery operation in spite of their alcohol addiction.
Many studies showed that a post surgery weaning syndrome increases morbidity and mortality.
So our study will focuses on the benefits of pre surgery medical weaning program.
The protocol is an open randomised, prospective study. The patient will be divided in two groups. In one hand, the first group is designed as "treated" will get alcohol weaning in the hospital alcohol department. The patient will be hospitalized during one week before the ORL surgery.
During this hospitalisation, the patient will receive medicinal treatment, medical follow-up and psychological counselling.
In the other hand, the second group designed as "control group" will be hospitalized directly in ORL surgery department. The patient will be received a treatment for alcohol weaning according to their symptom.
After their hospitalisation, the treated group will be followed-up regularly for their alcohol addiction either in support group or in individual counselling. The control group will be followed-up with the usual method in the ORL surgery department.
The expected result is to improve the care for patients with alcohol addiction and who must have an ORL surgery reducing the hospitalisation duration, the level of post operative complication and increasing the abstinence level. 115 patients will be included in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Procedure: Hospitalization for a weekpatient in hospital a week before the date of surgery for the treatment of his addiction alcohol |
| 1 | No intervention | –no treatment of his addiction alcohol during a week before the date of surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-80 years, male or female
- Clinically and histologically verified ORL cancer required surgery
- Patient with alcohol addiction
- Men must consume 21 glasses of wine a week
- Women must consume 14 glasses of wine a week
Key exclusion criteria (2 listed)
- Inability to give informed consent
- Patient with regulatory authority or private patient freedom
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 |
|---|---|---|
| Hospitalization for a weekPatient in hospital a week before the date of surgery for the treatment of their addiction to alcohol (alcohol weaning) | Procedure or surgery | 2 |
Primary outcome
The primary endpoint of the study will be to compare the duration of post surgery hospitalisation between the patients who benefit with an alcohol weaning and the patient treated with usual methods.
Time frame: two weeks
time between the surgery and the exit of the hospital
1 secondary outcome
The secondary objective is to note: the presence of weaning syndrome, the diagnostic of Delirium tremens, the occurrence of post surgeries complications.
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
Related trials for Cancer of the Upper Aero-digestive Tract
Recruiting
Impact of Adapted Aesthetic Onco in Patients With Upper Aerodigestive Tract Cancer During Their Management
Oncology, Aerodigestive Tract Cancer
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.
Albert TRAN, PhD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospitalization for a week in people with Cancer of the Upper Aero-digestive Tract and Alcoholism, run by Department of Clinical Research and Innovation at 1 site in France.
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 7 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: status not confirmed, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eve GELSI, MD (+33 4 92 03 60 18, gelsi.e@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study will be to compare the duration of post surgery hospitalisation between the patients who benefit with an alcohol weaning and the patient treated with usual methods. (time frame: two weeks). 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 26 Mar 2012.