Non-small Cell Bronchopulmonary Carcinoma at Stage IV and Benefiting From First-line Treatment According to Current French RecommendationsONCOGOUNCT05496556
Influence of Food Preferences on the Occurrence of Undernutrition in Treated Patients for Bronchopulmonary Carcinoma Non-small Cell Stage IV
A study testing Test Leeds Food Preference Questionnaire (LFQP-France) in people with Non-small Cell Bronchopulmonary Carcinoma at Stage IV and Benefiting From First-line Treatment According to Current French Recommendations, run by Centre Georges Francois Leclerc at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Bronchopulmonary Carcinoma at Stage IV and Benefiting From First-line Treatment According to Current French Recommendations
- What is being tested?
- Test Leeds Food Preference Questionnaire (LFQP-France)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- Test Leeds Food Preference Questionnaire (LFQP-France)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| All patients included in the study | Other | Patient with stage IV non-small cell bronchopulmonary carcinoma receiving first-line treatment and received LFQP questionnaire Receives: Other: Test Leeds Food Preference Questionnaire (LFQP-France) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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.
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
Measured: 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
The severity of malnutrition will be determined by serum albumin.
Measured: 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
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
Measured: 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)
1st line treatments considered categorized into 3 classes: platinum-based chemotherapy versus immunotherapy versus targeted therapy
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Nov 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Bronchopulmonary Carcinoma at Stage IV and Benefiting From First-line Treatment According to Current French RecommendationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496556
- Sponsor's protocol ID
- 2021-A01952-39
- Acronym
- ONCOGOU
- Status last verified
- Nov 2025
- First submitted
- 3 Aug 2022
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Food Preferences on the Occurrence of Undernutrition in Treated Patients for Bronchopulmonary Carcinoma Non-small Cell Stage IV
- ClinicalTrials.gov ID
- NCT05496556
- Acronym / sponsor ID
- ONCOGOU / 2021-A01952-39
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients included in the study | Other | Other: Test Leeds Food Preference Questionnaire (LFQP-France)Patient with stage IV non-small cell bronchopulmonary carcinoma receiving first-line treatment and received LFQP questionnaire |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test Leeds Food Preference Questionnaire (LFQP-France)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 | Other | All patients included in the study |
Primary outcome
Measurement of implicit wanting by the LFQP-France questionnaire
Time frame: 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
5 secondary outcomes
The occurrence of undernutrition within 6 months after inclusion, in patients not undernourished at inclusion
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Leeds Food Preference Questionnaire (LFQP-France) in people with Non-small Cell Bronchopulmonary Carcinoma at Stage IV and Benefiting From First-line Treatment According to Current French Recommendations, run by Centre Georges Francois Leclerc at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of implicit wanting by the LFQP-France questionnaire (time frame: During patient follow-up (12 months max)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.