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

NCT05496556 | Active Not Recruiting

• 1 other identifier: 2021-A01952-39
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Bronchopulmonary Carcinoma at Stage IV and Benefiting From First-line Treatment According to Current French Recommendations

Outcome Measures

Primary Outcomes (1)

• Measurement of implicit wanting by the LFQP-France questionnaire

  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

  During patient follow-up (12 months max)

Secondary Outcomes (5)

• The occurrence of undernutrition within 6 months after inclusion, in patients not undernourished at inclusion

  During 6 months

• 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 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 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

• 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

Study Arms (1)

All patients included in the study

OTHER

Patient with stage IV non-small cell bronchopulmonary carcinoma receiving first-line treatment and received LFQP questionnaire

Other: Test Leeds Food Preference Questionnaire (LFQP-France)

Interventions

Test Leeds Food Preference Questionnaire (LFQP-France) OTHER

The version of this questionnaire has been adapted to French eating habits. and based on the presentation of food photos, each representing one of the four categories below : salty-high in fat / salty-low fat / sugary-high fat / sweet-low fat The answers given to the LFQP predict a more or less caloric food intake. This tool makes it possible to objectify changes in eating behavior according to the nutritional status and protein status of patients. The implied wanting score for salty-high-fat, salty-low-fat, sweet-high-fat, and sweet-low-fat foods is calculated based on the frequency and speed of choice for one food type out of 150 combinations. For each of the food modalities, the software will return a score with its standard deviation. The modality preferred by the patient is the one with the highest score

All patients included in the study

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges-François Leclerc

Dijon, Côte d'Or, 21000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 11, 2022
• Study Start: November 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

FR (1)