Alcohol Addiction and Otorhinolaryngology Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00825448
First received: January 20, 2009
Last updated: March 23, 2012
Last verified: December 2011

January 20, 2009
March 23, 2012
January 2009
September 2012   (final data collection date for 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 ] [ Designated as safety issue: No ]
time between the surgery and the exit of the hospital
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00825448 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Alcohol Addiction and Otorhinolaryngology Cancer
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Cancer of the Upper Aero-digestive Tract
  • Alcoholism
Procedure: Hospitalization for a week
Patient in hospital a week before the date of surgery for the treatment of their addiction to alcohol (alcohol weaning)
  • Experimental: 2
    patient in hospital a week before the date of surgery for the treatment of his addiction alcohol
    Intervention: Procedure: Hospitalization for a week
  • No Intervention: 1
    no treatment of his addiction alcohol during a week before the date of surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
115
January 2013
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Eve GELSI, MD +33 4 92 03 60 18 gelsi.e@chu-nice.fr
Contact: Albert TRAN, PhD + 33 4 92 03 62 32 tran.a@chu-nice.fr
France
 
NCT00825448
2008-A00634-51
No
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
Department of Clinical Research and Innovation
National Cancer Institute, France
Principal Investigator: Albert TRAN, PhD CHU de Nice
Centre Hospitalier Universitaire de Nice
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP