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

January 23, 2018 updated by: Centre Oscar Lambret

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59 020
        • Oscar Lambret Center
      • Lille, France, 59 037
        • Centre Hospitalier Régional et Universitaire - Hopital HURIEZ
      • Lille, France, 59 037
        • Centre Hospitalier Régional et Universitaire - Hopital CALMETTE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Other: Addiction support
one consultation with an addiction specialist
No Intervention: Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
systematic addiction consultation
Time Frame: 12 months after diagnosis
difference between abstinence in group A and abstinence in group B
12 months after diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: 24 months after diagnosis
median time between date of inclusion and date of first progression
24 months after diagnosis
overall survival
Time Frame: 24 months after survival
median time between date of inclusion and date of death
24 months after survival
alcohol and tobacco consumption
Time Frame: baseline, 3 months, 6 months and 12 months after diagnosis
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.
baseline, 3 months, 6 months and 12 months after diagnosis
alcohol + tobacco withdrawal and addiction support
Time Frame: 12 months after diagnosis
difference between abstinence of group A and abstinence group B
12 months after diagnosis
addiction follow up
Time Frame: 24 months after diagnosis
percentage of patient with a first addiction consultation, and willing to have a long term follow up
24 months after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Study Director: Corinne VANNIMENUS, MD, Centre Hospitalier Regional Et Universitaire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

July 26, 2012

First Submitted That Met QC Criteria

July 26, 2012

First Posted (Estimate)

July 30, 2012

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTAKRA - 1205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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