Clinical trial NCT05496556: Influence of Food Preferences on the Occurrence of Undernutrition in Treated Patients for Bronchopulmonary Carcinoma Non-small Cell Stage IV
Official title: Influence of Food Preferences on the Occurrence of Undernutrition in Treated Patients for Bronchopulmonary Carcinoma Non-small Cell Stage IV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-small Cell Bronchopulmonary Carcinoma at Stage IV and Benefiting From First-line Treatment According to Current French Recommendations
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study will be offered to patients with non-small cell lung carcinoma diagnosed at stage IV and receiving first-line treatment.

The patient will benefit from a complete assessment at inclusion (clinical exam, imagery, biological exam, dietary consultation, test LFQP.

At the end of this 1st evaluation, patients in whom the diagnosis of undernutrition is made will benefit from dietary management with personalized advice that will take into account the symptoms of cancer, the possible side effects of treatments as well as the social environment.

Every two cures, i.e. every 4 to 6 weeks, these examens will be performed until the occurrence of an event (progression of the disease according to the RECIST criteria, death or change of therapeutic line). At the end of these assessments, patients will benefit from dietary management with a readjustment of personalized advice that will take into account the difficulties highlighted during the assessment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage IV non-small cell lung carcinoma with indication for first-line systemic treatment (chemotherapy, immunotherapy or specific treatment, in particular tyrosine kinase inhibitors) according to current French recommendations.
* Age over 18 and under 70
* Patient speaking and reading French fluently
* Affiliation to a social security scheme
* Patient able and willing to follow all study procedures in accordance with the protocol
* Patient having understood, signed and dated the consent form

Exclusion Criteria:

* Patient requiring hospitalization for more than 48 hours for the administration of the first course of treatment
* Patient benefiting from antibiotic therapy for the treatment of an acute infection
* Psychiatric, cognitive or neurological disorders making it impossible to assess food preferences and/or any impossibility to undergo medical monitoring for the trial for geographical, social or psychological reasons.
* Daily alcohol consumption
* Chest radiotherapy treatment
* Pregnant woman, likely to be, or breastfeeding
* Persons deprived of liberty or under guardianship

Primary outcomes:
measure: Measurement of implicit wanting by the LFQP-France questionnaire
timeFrame: During patient follow-up (12 months max)
Secondary outcomes:
measure: The occurrence of undernutrition within 6 months after inclusion, in patients not undernourished at inclusion
timeFrame: During 6 months
measure: The impact of food preferences (liking and explicit wanting) assessed by the LFQP-France questionnaire on the prevalence and incidence of undernutrition in the 6 months after inclusion.
timeFrame: During 6 months
measure: The impact of food preferences (liking, explicit lwanting and implicit wanting) assessed by the LFQP-France questionnaire on the severity of undernutrition
timeFrame: through study completion, an average of 1 year
measure: the impact of food preferences (liking, explicit wanting and implicit wanting) assessed by the LFQP-France questionnaire on quality of life
timeFrame: through study completion, an average of 1 year
measure: The impact of the type of 1st line treatment on food preferences (chemotherapy based on platinum salt versus immunotherapy versus targeted therapy)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges-François Leclerc
state: Côte d'Or
Study officials:
References: