Head and Neck CancerALTAKNCT01647425
Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer
An observational study of Head and Neck Cancer and Lung Cancer, run by Centre Oscar Lambret at 3 sites in France.
Trial summary
This is an multicenter study for preventive and therapeutic strategies for patients with head and neck cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Lung Cancer
- What is being tested?
- physician assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 385 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2012to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with a first head and neck cancer or first lung cancer
Who may be able to join
- first head and neck or lung cancer
- first support
- age ≥ 18
- patient covered by health insurance
- signed informed consent
Who cannot join
- prior lung or head and neck cancer
- History of another cancer <5 years, not evolutive and untreated at baseline (carcinoma of the cervix, or basal cell carcinoma of the skin properly treated are allowed). The presence of a second discovery tumor location at the same time as the lung or head and neck cancer, is not a criteria for non-inclusion
- mesothelioma and oesophageal cancer
- unable to undergo trail medical follow up (geographical, social and psychological reasons)
- pregnant or nursing women
- patient under guardianship
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier Régional et Universitaire - Hopital CALMETTE
Lille, 59 037
Centre Hospitalier Régional et Universitaire - Hopital HURIEZ
Lille, 59 037
Oscar Lambret Center
Lille, 59020
About this study
Official title: Prevalence and Risk Factors for Persistent Tobacco or Alcohol Use Over the First Year of a First Lung or Head and Neck Cancer
This is an multicenter study for preventive and therapeutic strategies for patients with head and neck cancer
Read the detailed description
Continuing the chronic intoxication by either tobacco or alcohol after the initial diagnosis of a first lung or head and neck cancer significantly improves the risk of experiencing a second cancer, and largely affects the long term survival. Addiction intervention programs should be personalized according to the patient's profile, with the aim to develop more sustained intervention and monitoring in patients identified at higher risk of not spontaneously stopping harmful substance use. As of today, the trajectories of smoking and drinking habits and the risk factors for persisting smoking or drinking habits have been insufficiently explored among patients with a first lung or head and neck cancer.
The ALTAK study aims to depict the rate of tobacco smokers 12 months after the initial diagnosis of a first lung or head and neck cancer. The secondary objectives of the study are:
- to depict the rate of alcohol users 12 months after the initial diagnosis of a H\&N cancer
- to depict the rate of tobacco smokers at cancer diagnosis
- to depict the rate of alcohol users at cancer diagnosis
- to determine the social, motivational, psychiatric, tobacco-related, alcohol-related, and cannabis-related features associated with stopping tobacco in the year following the diagnosis of a first TARC.
- to determine the social, psychiatric, tobacco-related, alcohol-related, and cannabis-related features associated with stopping alcohol drinking in the year following the diagnosis of a first H\&N cancer
- Conditions
- Head and Neck Cancer, Lung Cancer
- Being tested
- physician assessment
- Keywords
- head and neck cancer, lung cancer, tobacco use disorder, alcoholism
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Tobacco Use Disorder, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physician assessmentBehavioural
- Socio-economic conditions and general features: educational level, professional status...
- Assessment of current and past use of tobacco: current smoking status reported by the patient; in lifelong non-smokers: previous history of passive smoking reported by the patient; breath carbon monoxide level; in past smokers: age of first cigarette, total reported duration of active smoking, breath carbon monoxide level...
- in current smokers: age of first tobacco use, total reported duration of active smoking; Fagerström Nicotine Dependence Test...
- Assessment of the current and past uses of alcohol: previous-year assessment using the CAGE questionnaire and the AUDIT Test; average weekly alcohol consumption over the last 12 months...
- Assessment of current use of cannabis using the Cannabis Abuse Screening Test
- Psychiatric assessment using the MINI 5.0
| Study group | Role | What they receive |
|---|---|---|
| head and neck or lung cancer | patient with a first head and neck cancer or first lung cancer Receives: Behavioral: physician assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
tobacco consumption
reported tobacco smoking
Measured: at 12 months
Secondary outcomes (5)
tobacco smoking
frequency tobacco consumption
Measured: at baseline, 3 and 6 months
alcohol drinking
frequency of alcohol consumption
Measured: at baseline, 3, 6 and 12 months
progression free survival
median time between date of inclusion and date of first progression
Measured: at 12 months
overall survival
median time between date of inclusion and date of death
Measured: at 12 months
sociodemographic, cancer-related, tobacco-related, alcohol-related, and psychiatric characteristics
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Régional de Référence en Cancérologie, National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Corinne VANNIMENUS, MD, Study director, Centre Hospitalier Régional et Universitaire LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647425
- Sponsor's protocol ID
- ALTAK - 1109
- Other IDs
- 2011-A01659-32
- Acronym
- ALTAK
- Status last verified
- Mar 2026
- First submitted
- 19 Jul 2012
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vannimenus C, Bricout H, Le Rouzic O, Mouawad F, Chevalier D, Dansin E, Rotsaert L, Lefebvre G, Cottencin O, Porte H, Scherpereel A, El Fahsi A, Richard F, Rolland B; ALTAK Study Group. Compared characteristics of current vs. past smokers at the time of diagnosis of a first-time lung or head and neck cancer: a cross-sectional study. BMC Cancer. 2018 Apr 3;18(1):372. doi: 10.1186/s12885-018-4253-5.
PubMed 29614983
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors for Persistent Tobacco or Alcohol Use Over the First Year of a First Lung or Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01647425
- Acronym / sponsor ID
- ALTAK / ALTAK - 1109
- Conditions
- Head and Neck Cancer, Lung Cancer
- Keywords
- head and neck cancer, lung cancer, tobacco use disorder, alcoholism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Centre Régional de Référence en Cancérologie, National Cancer Institute, France
- Study start
- Apr 2012 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an multicenter study for preventive and therapeutic strategies for patients with head and neck cancer
Detailed description
Continuing the chronic intoxication by either tobacco or alcohol after the initial diagnosis of a first lung or head and neck cancer significantly improves the risk of experiencing a second cancer, and largely affects the long term survival. Addiction intervention programs should be personalized according to the patient's profile, with the aim to develop more sustained intervention and monitoring in patients identified at higher risk of not spontaneously stopping harmful substance use. As of today, the trajectories of smoking and drinking habits and the risk factors for persisting smoking or drinking habits have been insufficiently explored among patients with a first lung or head and neck cancer.
The ALTAK study aims to depict the rate of tobacco smokers 12 months after the initial diagnosis of a first lung or head and neck cancer. The secondary objectives of the study are:
- to depict the rate of alcohol users 12 months after the initial diagnosis of a H\&N cancer
- to depict the rate of tobacco smokers at cancer diagnosis
- to depict the rate of alcohol users at cancer diagnosis
- to determine the social, motivational, psychiatric, tobacco-related, alcohol-related, and cannabis-related features associated with stopping tobacco in the year following the diagnosis of a first TARC.
- to determine the social, psychiatric, tobacco-related, alcohol-related, and cannabis-related features associated with stopping alcohol drinking in the year following the diagnosis of a first H\&N cancer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| head and neck or lung cancer | – | Behavioral: physician assessmentpatient with a first head and neck cancer or first lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with a first head and neck cancer or first lung cancer
Key inclusion criteria (5 listed)
- first head and neck or lung cancer
- first support
- age ≥ 18
- patient covered by health insurance
- signed informed consent
Key exclusion criteria (6 listed)
- prior lung or head and neck cancer
- History of another cancer <5 years, not evolutive and untreated at baseline (carcinoma of the cervix, or basal cell carcinoma of the skin properly treated are allowed). The presence of a second discovery tumor location at the same time as the lung or head and neck cancer, is not a criteria for non-inclusion
- mesothelioma and oesophageal cancer
- unable to undergo trail medical follow up (geographical, social and psychological reasons)
- pregnant or nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physician assessment* Socio-economic conditions and general features: educational level, professional status... * Assessment of current and past use of tobacco: current smoking status reported by the patient; in lifelong non-smokers: previous history of passive smoking reported by the patient; breath carbon monoxide level; in past smokers: age of first cigarette, total reported duration of active smoking, breath carbon monoxide level... * in current smokers: age of first tobacco use, total reported duration of active smoking; Fagerström Nicotine Dependence Test... * Assessment of the current and past uses of alcohol: previous-year assessment using the CAGE questionnaire and the AUDIT Test; average weekly alcohol consumption over the last 12 months... * Assessment of current use of cannabis using the Cannabis Abuse Screening Test * Psychiatric assessment using the MINI 5.0 | Behavioural | head and neck or lung cancer |
Primary outcome
tobacco consumption
Time frame: at 12 months
reported tobacco smoking
5 secondary outcomes
tobacco smoking
Time frame: at baseline, 3 and 6 months
alcohol drinking
Time frame: at baseline, 3, 6 and 12 months
progression free survival
Time frame: at 12 months
overall survival
Time frame: at 12 months
sociodemographic, cancer-related, tobacco-related, alcohol-related, and psychiatric characteristics
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Derived from this study: PubMed 29614983Vannimenus C, Bricout H, Le Rouzic O, Mouawad F, Chevalier D, Dansin E, Rotsaert L, Lefebvre G, Cottencin O, Porte H, Scherpereel A, El Fahsi A, Richard F, Rolland B; ALTAK Study Group. Compared characteristics of current vs. past smokers at the time of diagnosis of a first-time lung or head and neck cancer: a cross-sectional study. BMC Cancer. 2018 Apr 3;18(1):372. doi: 10.1186/s12885-018-4253-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne VANNIMENUS, MD study director
Centre Hospitalier Régional et Universitaire LILLE
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Lung Cancer, run by Centre Oscar Lambret at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tobacco consumption (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01647425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.