Back to resultsInfluence of Food Preferences on the Occurrence of Undernutrition in Treated Patients for Bronchopulmonary Carcinoma Non-small Cell Stage IV (ONCOGOU)
Primary Purpose
Non-small Cell Bronchopulmonary Carcinoma at Stage IV and Benefiting From First-line Treatment According to Current French Recommendations
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Test Leeds Food Preference Questionnaire (LFQP-France)
Sponsored by
About this trial
This is an interventional other trial for Non-small Cell Bronchopulmonary Carcinoma at Stage IV and Benefiting From First-line Treatment According to Current French Recommendations
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
Sites / Locations
- Centre Georges-François LeclercRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All patients included in the study
Arm Description
Patient with stage IV non-small cell bronchopulmonary carcinoma receiving first-line treatment and received LFQP questionnaire
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The occurrence of undernutrition within 6 months after inclusion, in patients not undernourished at inclusion
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 and explicit wanting) assessed by the LFQP-France questionnaire on the prevalence and incidence of undernutrition in the 6 months after inclusion.
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 lwanting and implicit wanting) assessed by the LFQP-France questionnaire on the severity of undernutrition
The severity of malnutrition will be determined by serum albumin.
the impact of food preferences (liking, explicit wanting and implicit wanting) assessed by the LFQP-France questionnaire on quality of life
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 the type of 1st line treatment on food preferences (chemotherapy based on platinum salt versus immunotherapy versus targeted therapy)
1st line treatments considered categorized into 3 classes: platinum-based chemotherapy versus immunotherapy versus targeted therapy
Full Information
NCT ID
NCT05496556
First Posted
August 3, 2022
Last Updated
October 16, 2023
Sponsor
Centre Georges Francois Leclerc
1. Study Identification
Unique Protocol Identification Number
NCT05496556
Brief Title
Influence of Food Preferences on the Occurrence of Undernutrition in Treated Patients for Bronchopulmonary Carcinoma Non-small Cell Stage IV
Acronym
ONCOGOU
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Bronchopulmonary Carcinoma at Stage IV and Benefiting From First-line Treatment According to Current French Recommendations
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All patients included in the study
Arm Type
Other
Arm Description
Patient with stage IV non-small cell bronchopulmonary carcinoma receiving first-line treatment and received LFQP questionnaire
Intervention Type
Other
Intervention Name(s)
Test Leeds Food Preference Questionnaire (LFQP-France)
Intervention 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
Primary Outcome Measure Information:
Title
Measurement of implicit wanting by the LFQP-France questionnaire
Description
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
Time Frame
During patient follow-up (12 months max)
Secondary Outcome Measure Information:
Title
The occurrence of undernutrition within 6 months after inclusion, in patients not undernourished at inclusion
Description
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
Time Frame
During 6 months
Title
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.
Description
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
Time Frame
During 6 months
Title
The impact of food preferences (liking, explicit lwanting and implicit wanting) assessed by the LFQP-France questionnaire on the severity of undernutrition
Description
The severity of malnutrition will be determined by serum albumin.
Time Frame
through study completion, an average of 1 year
Title
the impact of food preferences (liking, explicit wanting and implicit wanting) assessed by the LFQP-France questionnaire on quality of life
Description
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
Time Frame
through study completion, an average of 1 year
Title
The impact of the type of 1st line treatment on food preferences (chemotherapy based on platinum salt versus immunotherapy versus targeted therapy)
Description
1st line treatments considered categorized into 3 classes: platinum-based chemotherapy versus immunotherapy versus targeted therapy
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie rs BETTING
Phone
0(3) 45 34 81 08
Ext
+33
Email
sbetting@cgfl.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marjolaine rs GEORGES, Pr
Phone
0(3) 80 29 37 72
Ext
+33
Email
marjolaine.georges@chu-dijon.fr
Facility Information:
Facility Name
Centre Georges-François Leclerc
City
Dijon
State/Province
Côte d'Or
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARJOLAINE GEORGES, Dr
Phone
03 80 29 37 72
Ext
+33
Email
marjolaine.georges@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Sophie PARNALLAND
Phone
03 45 34 80 77
Ext
+33
Email
sparnalland@cgfl.fr
12. IPD Sharing Statement
Learn more about this trial
Influence of Food Preferences on the Occurrence of Undernutrition in Treated Patients for Bronchopulmonary Carcinoma Non-small Cell Stage IV
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