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

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

NCT ID: NCT05496556

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

Conditions: Official terms:
Carcinoma
Malnutrition

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Test Leeds Food Preference Questionnaire (LFQP-France)
Description: 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
Arm group label: All patients included in the study

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Centre Georges-François Leclerc

Address:
City: Dijon
Zip: 21000
Country: France

Status: Recruiting

Contact:
Last name: MARJOLAINE GEORGES, Dr

Phone: 03 80 29 37 72

Phone ext: +33
Email: marjolaine.georges@chu-dijon.fr

Contact backup:
Last name: Sophie PARNALLAND

Phone: 03 45 34 80 77

Phone ext: +33
Email: sparnalland@cgfl.fr

Start date: November 1, 2023

Completion date: November 1, 2025

Lead sponsor:
Agency: Centre Georges Francois Leclerc
Agency class: Other

Source: Centre Georges Francois Leclerc

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05496556