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Completed

NCT Number: NCT02540174

Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Addiction Treatment

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)

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Key information

Conditions

Upper Aerodigestive Tract Neoplasms Behavior Head and Neck Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Tobacco Use

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU of Lille : Albert Calmette Hospital, Lille, France

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

integrated addiction treatment program

Procedure

At the inclusion, a 45 min 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 using the CO tester.

At 3, 6, and 12 months : a 20 min 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.

Standard of care

Procedure

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

Primary outcomes

  1. Difference in the rates of tobacco abstinent patients at 12 months between arms A and B

    Time frame: 1 year

    to be a "tobacco abstinent" patient has to :

    • be a smoker at the inclusion (M0)
    • declare to be weaned at M6
    • not declare a consumption between M6 and M12
    • a CO rate less than 10 ppm measured with a CO test at M6 and M12

    We compare the two arms in term of tobacco abstinent patients rate.

Secondary outcomes

  1. Frequency of alcohol and tobacco consumptions during the study

    Time frame: initial diagnosis, after 3, 6 and 12 months

    We considere the tobacco and alcohol consumption levels at T0, M3, M6, M12 by the consumption statement and the behaviour change towards tobacco and alcohol, thanks to questionnaires study specific.

  2. Percentage of tobacco abstinent patients at 12 months

    Time frame: 1 year

    to be a "tobacco abstinent" patient has to :

    • be a smoker at the inclusion (M0)
    • declare to be weaned at M6
    • not declare a consumption between M6 and M12
    • a CO rate less than 10 ppm measured with a CO test at M6 and M12

    We calculate the percentage of tobacco abstinent patients at 12 months considering every patient in the trial.

  3. 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

    We use a specialized monitoring in addictology (tobacco/alcohol) at 12 months according to the arms. The information of a monitoring in addictology will be obtained by the study specific questionnaire at M3, M6, M12

  4. Median time between inclusion date and the date of death (from any cause)

    Time frame: 1 year

    Time until progression. The time between the date of inclusion and the date of death whatever the cause is.

  5. Median progression-free time

    Time frame: 1 year

    delay between inclusion date and progression date (clinical or radiological)

  6. Percentage of Arm A patients who attended the addiction treatment program after the first systematic consultation

    Time frame: 1 year

    We note for each patient in arm A if they have at least one addictology specialized consultation after the first consultation which is imposed, during the 12 months

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Centre Régional de Référence en Cancérologie
  • National Cancer Institute, France

Registry information

Official study 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

Acronym: ALTAKRA-1405

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 3, 2015
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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