Influence of Food Preferences on the Occurrence of Undernutrition in Treated Patients for Bronchopulmonary Carcinoma Non-small Cell Stage IV

Not Applicable

Recruiting

• Conditions: Non-small Cell Bronchopulmonary Carcinoma at Stage IV and Benefiting From First-line Treatment According to Current French Recommendations
• Interventions: Other: Test Leeds Food Preference Questionnaire (LFQP-France)

• Registration Number: NCT05496556
• Lead Sponsor: Centre Georges Francois Leclerc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2023-11-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients included in the study	Test Leeds Food Preference Questionnaire (LFQP-France)	Patient with stage IV non-small cell bronchopulmonary carcinoma receiving first-line treatment and received LFQP questionnaire

Primary Outcome Measures

Name	Time	Method
Measurement of implicit wanting by the LFQP-France questionnaire	During patient follow-up (12 months max)	The food category with the highest implicit wanting score will be retained as characterizing the patient's food preferences. The 4 categories concerned are as follows: * salty high in fat; * salty-low fat; * sweet-high fat; * sweet-low fat

Secondary Outcome Measures

Name	Time	Method
The impact of food preferences (liking, explicit lwanting and implicit wanting) assessed by the LFQP-France questionnaire on the severity of undernutrition	through study completion, an average of 1 year	The severity of malnutrition will be determined by serum albumin.
The occurrence of undernutrition within 6 months after inclusion, in patients not undernourished at inclusion	During 6 months	The food category with the highest implicit wanting score will be retained as characterizing the patient's food preferences. The 4 categories concerned are as follows: * salty high in fat; * salty-low fat; * sweet-high fat; * sweet-low fat
the impact of food preferences (liking, explicit wanting and implicit wanting) assessed by the LFQP-France questionnaire on quality of life	through study completion, an average of 1 year	With the EORTC QLQ-C30 and QLQ-CL13 tests at inclusion, then at each follow-up visit and until exit from the study (premature exit or end of study
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.	During 6 months	The food category with the highest implicit wanting score will be retained as characterizing the patient's food preferences. The 4 categories concerned are as follows: * salty high in fat; * salty-low fat; * sweet-high fat; * sweet-low fat
The impact of the type of 1st line treatment on food preferences (chemotherapy based on platinum salt versus immunotherapy versus targeted therapy)	through study completion, an average of 1 year	1st line treatments considered categorized into 3 classes: platinum-based chemotherapy versus immunotherapy versus targeted therapy

Trial Locations

Locations (1)

Centre Georges-François Leclerc; 🇫🇷 Dijon, Côte d'Or, France