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Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Addiction Treatment (ALTAKRA-1405)

C

Centre Oscar Lambret

Status

Completed

Conditions

Lung Cancer
Upper Aerodigestive Tract Neoplasms

Treatments

Procedure: integrated addiction treatment program
Procedure: standard of care

Study type

Interventional

Funder types

Other

Identifiers

NCT02540174
ALTAKRA-1405

Details and patient eligibility

About

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)

Full 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.

Enrollment

133 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

133 participants in 2 patient groups

Arm A
Experimental group
Description:
integrated addiction treatment program
Treatment:
Procedure: integrated addiction treatment program
Arm B
Other group
Description:
standard of care
Treatment:
Procedure: standard of care

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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