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Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Addiction Treatment (ALTAKRA-1405)

This study is currently recruiting participants.
Verified September 2015 by Centre Oscar Lambret
Sponsor:
ClinicalTrials.gov Identifier:
NCT02540174
First Posted: September 3, 2015
Last Update Posted: September 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Centre Régional de Référence en Cancérologie
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Oscar Lambret
  Purpose
This is a multicenter, interventional, randomized study among patients with a first lung or head & neck cancer who are still active smokers ± alcohol misusers.The study will aim to compare the systematic implementation of an addiction treatment program initiated at hospital and integrated to the initial cancer treatment program (Arm A), versus the as-usual procedure, which consists in recommendations to follow an addiction treatment program (Arm B)

Condition Intervention
Upper Aerodigestive Tract Neoplasms Lung Cancer Procedure: integrated addiction treatment program Procedure: standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of Integrating the Addiction Treatment to the Initial Cancer Treatment Program

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Difference in the rates of tobacco abstinent patients at 12 months between arms A and B [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Frequency of alcohol and tobacco consumptions during the study [ Time Frame: initial diagnosis, after 3, 6 and 12 months ]
  • Percentage of tobacco abstinent patients at 12 months [ Time Frame: 1 year ]
  • Difference in the rates of alcohol and tobacco abstinent patients at 12 months depending on whether or not they have received an addiction treatment [ Time Frame: 1 year ]
  • Median time between inclusion date and the date of death (from any cause) [ Time Frame: 1 year ]
  • Median progression-free time [ Time Frame: 1 year ]
    delay between inclusion date and progression date (clinical or radiological)

  • Percentage of Arm A patients who attended the addiction treatment program after the first systematic consultation [ Time Frame: 1 year ]

Estimated Enrollment: 242
Study Start Date: May 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
integrated addiction treatment program
Procedure: integrated addiction treatment program

At the inclusion, a 45 minutes interview for : the completion of questionnaires (Fagerström, AUDIT, CAST, Socrates, M.I.N.I) , the collection of socio-professional information, obstacles and incentives to stop the consumption of alcohol and tobacco, the record of alcohol-tobacco consumptions, the measurement of exhaled carbone monoxide rate expressed in particles per million (ppm) using the CO tester.

  • At 3, 6, and 12 months: a 20 minutes interview to assess the alcohol-tobacco consumption and the obstacles and incentives to stop the consumption.

The first addiction consultation will be carried out directly in the cancer treatment unit, and integrated to the overall cancer treatment program. This first addiction consultation will concern :

  • For patients with lung cancer: tobacco and addiction or harmful use of alcohol according to classical criteria
  • For patients with upper aerodigestive tract cancer: tobacco and any use of alcohol
Arm B
standard of care
Procedure: standard of care

The following actions will be performed by a nurse or by the study coordinator on site who have been trained in tobaccology and addictology :

  • At the inclusion, a 45 minutes interview for : the completion of questionnaires (Fagerström, AUDIT, CAST, Socrates, M.I.N.I) , the collection of socio-professional information, obstacles and incentives to stop the consumption of alcohol and tobacco, the record of alcohol-tobacco consumptions, the measurement of exhaled carbone monoxide rate expressed in particles per million (ppm) using the CO tester.
  • At 3, 6, and 12 months: a 20 minutes interview to assess the alcohol-tobacco consumption and the obstacles and incentives to stop the consumption

Detailed Description:
  • Study proposal at the first medical consultation for therapeutic management of a first upper aerodigestive tract cancer or lung cancer.
  • Selection criteria validation
  • Collection of an informed consent
  • Randomization :

Arm A: Experimental arm : Addiction consultation to the overall cancer treatment

Arm B: standard of care

The completion of questionnaires , the measurement of exhaled carbone monoxide rate using a CO tester for all patients, and the integrated addiction treatment among patients randomized in Arm A will not interfere with the medical treatment of cancer.

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a first upper aerodigestive tract cancer or a lung cancer
  • Initial cancer treatment
  • Aged ≥ 18 and ≤65 years
  • Living within a radius of 20 km from the CHRU de Lille/Oscar Lambret Center
  • Patient with tobacco addiction: regular smoker = at least 7 cigarettes /week or 1 cigarette/day or short-term ex-smoker = regular smoker who has stopped smoking for less than 1 year from the inclusion date
  • Performance status (ECOG/WHO) ≤ 2
  • Registered with a social security system
  • Informed and signed consent collected before initiation of any study procedures

Exclusion Criteria:

  • Previous lung cancer or upper aerodigestive tract cancer
  • Previous other cancer < 5 years, evoluting or treated at the inclusion (except uterine cervical carcinoma, basal cell or squamous cell skin carcinoma )
  • Mesothelioma and esophageal cancer
  • Occasional smoker (less than 7 cigarettes/week or less than 1 cigarette/day)
  • Long-term ex-smokers who have stopped smoking for more than 1 year from the inclusion date
  • Impossibility to comply with the study procedures due to geographic, social or mental reasons
  • Patient under guardianship or tutorship
  • Pregnant or breastfeeding women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540174


Contacts
Contact: Corinne Vannimenus, MD + 33 3 20 44 66 55 corinne.vannimenus@chru-lille.fr

Locations
France
Oscar Lambret Center Recruiting
Lille, France, 59020
Contact: Gauthier Lefebvre, MD    +33 3 20 29 59 39    g-lefebvre@o-lambret.fr   
Principal Investigator: Gauthier Lefebvre, MD         
CHRU of Lille : Albert Calmette Hospital Recruiting
Lille, France, 59037
Contact: Arnaud Scherpereel, MD, PhD    +33 3 20 44 56 12    arnaud.scherpereel@chru-lille.fr   
Principal Investigator: Arnaud Scherpereel, MD, PhD         
Sub-Investigator: Corinne Vannimenus, MD         
CHRU of Lille: Huriez Hospital Recruiting
Lille, France, 59037
Contact: Dominique Chevalier, MD    +33 3 20 44 66 86    dominique.chevalier@chru-lille.fr   
Principal Investigator: Dominique Chevalier, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Centre Régional de Référence en Cancérologie
National Cancer Institute, France
Investigators
Study Director: Corinne Vannimenus, MD CHRU of Lille
  More Information

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT02540174     History of Changes
Other Study ID Numbers: ALTAKRA-1405
First Submitted: September 1, 2015
First Posted: September 3, 2015
Last Update Posted: September 18, 2015
Last Verified: September 2015

Keywords provided by Centre Oscar Lambret:
alcohol and tobacco consumption
addiction treatment

Additional relevant MeSH terms:
Lung Neoplasms
Behavior, Addictive
Head and Neck Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Compulsive Behavior
Impulsive Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs