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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01652456
Other study ID # ALTAKRA - 1205
Secondary ID
Status Withdrawn
Phase N/A
First received July 26, 2012
Last updated January 23, 2018
Start date October 2012
Est. completion date November 2017

Study information

Verified date August 2014
Source Centre Oscar Lambret
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Intervention

Other:
Addiction support
one consultation with an addiction specialist

Locations

Country Name City State
France Centre Hospitalier Régional et Universitaire - Hopital CALMETTE Lille
France Centre Hospitalier Régional et Universitaire - Hopital HURIEZ Lille
France Oscar Lambret Center Lille

Sponsors (1)

Lead Sponsor Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary systematic addiction consultation difference between abstinence in group A and abstinence in group B 12 months after diagnosis
Secondary progression free survival median time between date of inclusion and date of first progression 24 months after diagnosis
Secondary overall survival median time between date of inclusion and date of death 24 months after survival
Secondary 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. baseline, 3 months, 6 months and 12 months after diagnosis
Secondary alcohol + tobacco withdrawal and addiction support difference between abstinence of group A and abstinence group B 12 months after diagnosis
Secondary addiction follow up percentage of patient with a first addiction consultation, and willing to have a long term follow up 24 months after diagnosis
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