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.
Verified July 2012 by Centre Oscar Lambret
Sponsor:
Centre Oscar Lambret
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
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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
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: L’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 May 19, 2013