Alcohol Addiction and Otorhinolaryngology Cancer
Primary Purpose
Cancer of the Upper Aero-digestive Tract, Alcoholism
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hospitalization for a week
Sponsored by
About this trial
This is an interventional prevention trial for Cancer of the Upper Aero-digestive Tract focused on measuring alcohol addiction
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inability to give informed consent
- Patient with regulatory authority or private patient freedom
Sites / Locations
- Fédération des maladies de l'appareil digestif - Hôpital ARCHETRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
2
1
Arm Description
patient in hospital a week before the date of surgery for the treatment of his addiction alcohol
no treatment of his addiction alcohol during a week before the date of surgery
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The secondary objective is to note: the presence of weaning syndrome, the diagnostic of Delirium tremens, the occurrence of post surgeries complications.
Full Information
NCT ID
NCT00825448
First Posted
January 20, 2009
Last Updated
March 23, 2012
Sponsor
Department of Clinical Research and Innovation
Collaborators
National Cancer Institute, France
1. Study Identification
Unique Protocol Identification Number
NCT00825448
Brief Title
Alcohol Addiction and Otorhinolaryngology Cancer
Official Title
Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Department of Clinical Research and Innovation
Collaborators
National Cancer Institute, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Upper Aero-digestive Tract, Alcoholism
Keywords
alcohol addiction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Experimental
Arm Description
patient in hospital a week before the date of surgery for the treatment of his addiction alcohol
Arm Title
1
Arm Type
No Intervention
Arm Description
no treatment of his addiction alcohol during a week before the date of surgery
Intervention Type
Procedure
Intervention Name(s)
Hospitalization for a week
Intervention Description
Patient in hospital a week before the date of surgery for the treatment of their addiction to alcohol (alcohol weaning)
Primary Outcome Measure Information:
Title
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.
Description
time between the surgery and the exit of the hospital
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Inability to give informed consent
Patient with regulatory authority or private patient freedom
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eve GELSI, MD
Phone
+33 4 92 03 60 18
Email
gelsi.e@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Albert TRAN, PhD
Phone
+ 33 4 92 03 62 32
Email
tran.a@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert TRAN, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fédération des maladies de l'appareil digestif - Hôpital ARCHET
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eve Gelsi, MD
Phone
+ 33 4 92 03 60 18
Email
gelsi.e@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Albert Tran, PhD
Phone
+ 33 4 92 03 62 32
Email
tran.a@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Albert Tran, PhD
12. IPD Sharing Statement
Learn more about this trial
Alcohol Addiction and Otorhinolaryngology Cancer
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