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

18 Years
80 Years
Open (Enrolling)
Cancer of the Upper Aero-digestive Tract, Alcoholism

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Trial Information

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

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

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

Type of Study:


Study Design:

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

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.

Outcome Description:

time between the surgery and the exit of the hospital

Outcome Time Frame:

two weeks

Safety Issue:


Principal Investigator

Albert TRAN, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU de Nice


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

January 2009

Completion Date:

January 2013

Related Keywords:

  • Cancer of the Upper Aero-digestive Tract
  • Alcoholism
  • alcohol addiction
  • Alcoholism
  • Behavior, Addictive