Alcohol and Tobacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by Centre Oscar Lambret
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01652456
First received: July 26, 2012
Last updated: July 30, 2012
Last verified: July 2012
  Purpose

This is a multicenter, interventional, randomized study for preventive and therapeutic strategies for patients with head and neck or Lung cancer; contribution of an addiction support


Condition Intervention
Head and Neck Cancer
Lung Cancer
Other: Addiction support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Alcohol and TObacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • systematic addiction consultation [ Time Frame: 12 months after diagnosis ] [ Designated as safety issue: No ]
    difference between abstinence in group A and abstinence in group B


Secondary Outcome Measures:
  • progression free survival [ Time Frame: 24 months after diagnosis ] [ Designated as safety issue: No ]
    median time between date of inclusion and date of first progression

  • overall survival [ Time Frame: 24 months after survival ] [ Designated as safety issue: No ]
    median time between date of inclusion and date of death

  • alcohol and tobacco consumption [ Time Frame: baseline, 3 months, 6 months and 12 months after diagnosis ] [ Designated as safety issue: No ]
    frequency of tobacco and alcohol consumption questionnaire : Fagerström, Alcohol Use Disorders Identification Test (AUDIT), Cut Down Annoyed Guilty Eye-Opener (CAGE-DETA), Cannabis abuse screening test (CAST), M.I.N.I.

  • alcohol + tobacco withdrawal and addiction support [ Time Frame: 12 months after diagnosis ] [ Designated as safety issue: No ]
    difference between abstinence of group A and abstinence group B

  • addiction follow up [ Time Frame: 24 months after diagnosis ] [ Designated as safety issue: No ]
    percentage of patient with a first addiction consultation, and willing to have a long term follow up


Estimated Enrollment: 230
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Other: Addiction support
one consultation with an addiction specialist
No Intervention: Group B

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • first head and neck or lung cancer
  • first support
  • 18 ≤ age ≤ 60
  • lives in Lille Metropolis
  • having an addiction to alcohol and tobacco
  • covered by health insurance
  • signed informed consent

Exclusion Criteria:

  • prior cancer
  • mesothelioma and oesophageal cancer
  • unable to undergo trail medical follow up (geographical, social and psychological reasons)
  • pregnant or nursing woman
  • patient under guardianship
  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: NCT01652456

Contacts
Contact: Corinne VANNIMENUS, MD +33 (0)3.20.44.66.55 corinne.vannimenus@chru-lille.fr

Locations
France
Oscar Lambret Center Not yet recruiting
Lille, France, 59 020
Contact: Jean-Louis LEFEBVRE, MD PhD    +33 (0)3.20.29.59.20    jl-lefebvre@o-lambret.fr   
Principal Investigator: Jean-Louis LEFEBVRE, MD PhD         
Sub-Investigator: Sophie EL BEDOUI, MD         
Sub-Investigator: Jean TON VAN, MD         
Sub-Investigator: Yann MALLET, MD         
Sub-Investigator: Gauthier LEFEBVRE, MD         
Sub-Investigator: Marian DEGARDIN, MD         
Sub-Investigator: Eric DANSIN, MD         
Sub-Investigator: Alain JOVENIAUX, MD         
Centre Hospitalier Régional et Universitaire - Hopital CALMETTE Not yet recruiting
Lille, France, 59 037
Contact: Corinne VANNIMENUS, MD    +33 (0)3.20.44.66.55    corinne.vannimenus@chru-lille.fr   
Principal Investigator: Arnaud SCHERPEREEL, MDPhD         
Sub-Investigator: Corinne VANNIMENUS, MD         
Sub-Investigator: Olivier COTTENCIN, MD         
Sub-Investigator: Benjamin ROLLAND, MD         
Centre Hospitalier Régional et Universitaire - Hopital HURIEZ Not yet recruiting
Lille, France, 59 037
Contact: Corinne VANNIMENUS, MD    +33 (0)3.20.44.66.55    corinne.vannimenus@chru-lille.fr   
Principal Investigator: Dominique CHEVALIER, MD         
Sub-Investigator: Xavier PASQUESOONE, MD         
Sub-Investigator: Geoffrey MORTUAIRE, MD         
Sub-Investigator: Olivier COTTENCIN, MD         
Sub-Investigator: Benjamin ROLLAND, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Study Director: Corinne VANNIMENUS, MD Centre Hospitalier Régional et Universitaire
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01652456     History of Changes
Other Study ID Numbers: ALTAKRA - 1205
Study First Received: July 26, 2012
Last Updated: July 30, 2012
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Oscar Lambret:
addiction support
addiction specialist
lung cancer
head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Lung Neoplasms
Behavior, Addictive
Neoplasms by Site
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Compulsive Behavior
Impulsive Behavior

ClinicalTrials.gov processed this record on July 23, 2014