Head and Neck CancerNCT01652456
Alcohol and Tobacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support
A study testing Addiction support in people with Head and Neck Cancer and Lung Cancer, run by Centre Oscar Lambret at 3 sites in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Head and Neck Cancer, Lung Cancer
- What is being tested?
- Addiction support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesFrance
- Study dates
- Oct 2012to Nov 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Oscar Lambret Center
Lille, 59 020
Centre Hospitalier Régional et Universitaire - Hopital CALMETTE
Lille, 59 037
Centre Hospitalier Régional et Universitaire - Hopital HURIEZ
Lille, 59 037
About this study
Official title: 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
- Conditions
- Head and Neck Cancer, Lung Cancer
- Being tested
- Addiction support
- Keywords
- addiction support, addiction specialist, lung cancer, head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addiction supportOther
one consultation with an addiction specialist
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Other: Addiction support |
| Group B | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
systematic addiction consultation
difference between abstinence in group A and abstinence in group B
Measured: 12 months after diagnosis
Secondary outcomes (5)
progression free survival
median time between date of inclusion and date of first progression
Measured: 24 months after diagnosis
overall survival
median time between date of inclusion and date of death
Measured: 24 months after survival
alcohol and tobacco consumption
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.
Measured: baseline, 3 months, 6 months and 12 months after diagnosis
alcohol + tobacco withdrawal and addiction support
difference between abstinence of group A and abstinence group B
Measured: 12 months after diagnosis
addiction follow up
percentage of patient with a first addiction consultation, and willing to have a long term follow up
Measured: 24 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corinne VANNIMENUS, MD, Study director, Centre Hospitalier Régional et Universitaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652456
- Sponsor's protocol ID
- ALTAKRA - 1205
- Status last verified
- Aug 2014
- First submitted
- 26 Jul 2012
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. 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 Cancer : Interest of an Addiction Support
- ClinicalTrials.gov ID
- NCT01652456
- Acronym / sponsor ID
- ALTAKRA - 1205
- Conditions
- Head and Neck Cancer, Lung Cancer
- Keywords
- addiction support, addiction specialist, lung cancer, head and neck cancer
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 30 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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Addiction support |
| Group B | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- first head and neck or lung cancer
- first support
- 18 ≤ age ≤ 60
- lives in Lille Metropolis
- having an addiction to alcohol and tobacco
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Addiction supportone consultation with an addiction specialist | Other | Group A |
Primary outcome
systematic addiction consultation
Time frame: 12 months after diagnosis
difference between abstinence in group A and abstinence in group B
5 secondary outcomes
progression free survival
Time frame: 24 months after diagnosis
overall survival
Time frame: 24 months after survival
alcohol and tobacco consumption
Time frame: baseline, 3 months, 6 months and 12 months after diagnosis
alcohol + tobacco withdrawal and addiction support
Time frame: 12 months after diagnosis
addiction follow up
Time frame: 24 months after diagnosis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addiction support in people with 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 7 inclusion and 5 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: withdrawn, as of the sponsor's last update on 24 Jan 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
systematic addiction consultation (time frame: 12 months after diagnosis). 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 24 Jan 2018.