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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
  Purpose

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.


Condition Intervention
Cancer of the Upper Aero-digestive Tract
Alcoholism
Procedure: Hospitalization for a week

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

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 Frame: two weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 115
Study Start Date: January 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
patient in hospital a week before the date of surgery for the treatment of his addiction alcohol
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)
No Intervention: 1
no treatment of his addiction alcohol during a week before the date of surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825448

Contacts
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

Locations
France
Fédération des maladies de l'appareil digestif - Hôpital ARCHET Recruiting
Nice, France, 06202
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   
Principal Investigator: Albert Tran, PhD         
Sponsors and Collaborators
Department of Clinical Research and Innovation
National Cancer Institute, France
Investigators
Principal Investigator: Albert TRAN, PhD CHU de Nice
  More Information

No publications provided

Responsible Party: Department of Clinical Research and Innovation, Department of Clinical Research and Innovation (drc), Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00825448     History of Changes
Other Study ID Numbers: 2008-A00634-51
Study First Received: January 20, 2009
Last Updated: March 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority
France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:
alcohol addiction

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014