Upper Aerodigestive Tract NeoplasmsALTAKRA-1405NCT02540174
Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Addiction Treatment
A study testing integrated addiction treatment program in people with Upper Aerodigestive Tract Neoplasms and Lung Cancer, run by Centre Oscar Lambret at 3 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Aerodigestive Tract Neoplasms, Lung Cancer
- What is being tested?
- integrated addiction treatment program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 3 sitesFrance
- Study dates
- 27 May 2015to 12 Dec 2017
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Oscar Lambret Center
Lille, 59020
CHRU of Lille : Albert Calmette Hospital
Lille, 59037
CHRU of Lille: Huriez Hospital
Lille, 59037
About this study
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
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)
Read the 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.
- Conditions
- Upper Aerodigestive Tract Neoplasms, Lung Cancer
- Being tested
- integrated addiction treatment program, standard of care
- Keywords
- alcohol and tobacco consumption, addiction treatment
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated addiction treatment programProcedure or surgery
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 careProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | integrated addiction treatment program Receives: Procedure: integrated addiction treatment program |
| Arm B | Other | standard of care Receives: Procedure: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the rates of tobacco abstinent patients at 12 months between arms A and B
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.
Measured: 1 year
Secondary outcomes (6)
Frequency of alcohol and tobacco consumptions during the study
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.
Measured: initial diagnosis, after 3, 6 and 12 months
Percentage of tobacco abstinent patients at 12 months
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.
Measured: 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
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
Measured: 1 year
Median time between inclusion date and the date of death (from any cause)
Time until progression. The time between the date of inclusion and the date of death whatever the cause is.
Measured: 1 year
Median progression-free time
delay between inclusion date and progression date (clinical or radiological)
Measured: 1 year
Percentage of Arm A patients who attended the addiction treatment program after the first systematic consultation
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study start27 May 2015
- Primary completion9 Nov 2016
- Study completion12 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Aerodigestive Tract NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 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, CHRU of Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540174
- Sponsor's protocol ID
- ALTAKRA-1405
- Other IDs
- 2014-A01578-39
- Acronym
- ALTAKRA-1405
- Status last verified
- Mar 2026
- First submitted
- 1 Sep 2015
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02540174
- Acronym / sponsor ID
- ALTAKRA-1405 / ALTAKRA-1405
- Conditions
- Upper Aerodigestive Tract Neoplasms, Lung Cancer
- Keywords
- alcohol and tobacco consumption, addiction treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Centre Régional de Référence en Cancérologie, National Cancer Institute, France
- Study start
- 27 May 2015 (actual)
- Primary completion
- 9 Nov 2016 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 3 Sep 2015 (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 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)
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Procedure: integrated addiction treatment programintegrated addiction treatment program |
| Arm B | Other | Procedure: standard of carestandard of care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| integrated addiction treatment programAt 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. | Procedure or surgery | Arm A |
| standard of careThe 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 | Procedure or surgery | Arm B |
Primary outcome
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.
6 secondary outcomes
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
Percentage of Arm A patients who attended the addiction treatment program after the first systematic consultation
Time frame: 1 year
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 13 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Upper Aerodigestive Tract Neoplasms
RecruitingObservational study
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Esophageal Cancer, Head and Neck Cancer
Active, not recruitingPhase 2
Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC
Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies
Head and Neck Cancer, Lung Cancer
Active, not recruitingPhase 2
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
Active, not recruitingObservational study
Integrated Molecular Profiling in Advanced Cancers Trial
Breast Cancer, Non-small Cell Lung Cancer
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
CHRU of Lille
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrated addiction treatment program in people with Upper Aerodigestive Tract Neoplasms 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 8 inclusion and 8 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 13 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?
Difference in the rates of tobacco abstinent patients at 12 months between arms A and B (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2026.