Alcohol Addiction and Otorhinolaryngology Cancer

Alcoholism Clinical Trial

Official title:

Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00825448
• Other study ID #: 2008-A00634-51
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2009
• Last updated: March 23, 2012
• Start date: January 2009
• Est. completion date: January 2013

Study information

• Verified date: December 2011
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Eve GELSI, MD
• Phone: +33 4 92 03 60 18
• Email: gelsi.e[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: January 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcoholism
• Cancer of the Upper Aero-digestive Tract

Intervention

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)

Locations

Country	Name	City	State
France	Fédération des maladies de l'appareil digestif - Hôpital ARCHET	Nice

Sponsors (2)

Lead Sponsor	Collaborator
Department of Clinical Research and Innovation	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	two weeks	No
Secondary	The secondary objective is to note: the presence of weaning syndrome, the diagnostic of Delirium tremens, the occurrence of post surgeries complications.		two years	No