Carcinoma, Non-Small-Cell LungLUNGDIETNCT06068088
Dietary Practices and Locally Advanced Lung Cancer (LUNGDIET)
An observational study of Carcinoma, Non-Small-Cell Lung, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
In recent years, fasting or the use of special diets (ketogenic, high protein, etc.), whether or not associated with food supplements, have increased substantially, particularly in oncology with the idea of improving for some of them, the tolerance of the proposed treatments, in particular emetogenic chemotherapy, or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Self-administered survey at hospital, Blood sample for nutritional assessment and Consultation with nutritionist doctor and dietician
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study is aimed at patients treated with radiochemotherapy for non-small cell lung cancer localized in thorax. The choice of this population is based on its frequency, its clinical homogeneity, the prospect of a curative treatment but with a clearly improvable prognosis and the absence of published data on the subject.
Who may be able to join
- Histologically documented inoperable stage III non-small cell lung carcinoma (no metastasis)
- Treatment with curative intent including thoracic radiotherapy and at least one cycle of concomitant chemotherapy
- Patient informed and having signed the consent
Who cannot join
- Sequential radiochemotherapy
- Metastatic forms from the outset
- Ear, nose, and throat (ENT) or digestive pathologies interfering with normal oral nutrition
- Other concurrent or pre-existing cancer for less than 5 years at the diagnosis of bronchial cancer
- Patient under guardianship or curatorship
- Patient with cognitive impairment
Show all 9Show fewer
- Patient not affiliated with a social security
- Patient under state medical help from french government
- Radiotherapy performed outside the AP-HP for cohort A and outside the HEGP for cohort B
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Preliminary Survey of Dietary Practices and Nutritional Status of Patients Treated With Radiochemotherapy for Non-small Cell Lung Carcinoma
In recent years, fasting or the use of special diets (ketogenic, high protein, etc.), whether or not associated with food supplements, have increased substantially, particularly in oncology with the idea of improving for some of them, the tolerance of the proposed treatments, in particular emetogenic chemotherapy, or even to improve the prognosis. Although there are preclinical data on cell cultures and in rats, the clinical data supporting these practices are very fragmented, with few trials carried out and only including small cohorts, mainly in the context of breast cancers. It is therefore very difficult to respond objectively to patients asking the question of the merits of these changes in dietary practices in the management of their cancer.
The investigators want to carry out an inventory of the dietary practices of participating patients and their potential interest in fasting or special diets by means of a self-administered survey completed by the patient at diagnosis before treatment. This semi-quantitative self-administered survey (answers in never / sometimes / regularly / systematically) was developed by the nutrition and radiotherapy team of the Georges-Pompidou European Hospital because there was no validated medical questionnaire on fasting or the use of special diets in oncology
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Self-administered survey at hospital, Blood sample for nutritional assessment, Consultation with nutritionist doctor and dietician
- Keywords
- Radiochemotherapy, Fasting, Special diet
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered survey at hospitalBehavioural
Self-administered survey on the food practices of the patient Completion before the beginning of chemoradiotherapy
Blood sample for nutritional assessmentBiological
15 ml of blood sampled during nutritional examination before the beginning and during the month following the end of chemoradiotherapy
Consultation with nutritionist doctor and dieticianOther
Before the beginning and during the month following the end of chemoradiotherapy Consultation of approximatively one hour
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Participating patients from 5 radiotherapy center of AP-HP Receives: Behavioral: Self-administered survey at hospital | |
| Cohort B | Participating patients from the european hospital Georges-Pompidou Receives: Behavioral: Self-administered survey at hospital; Biological: Blood sample for nutritional assessment; Other: Consultation with nutritionist doctor and dietician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inventory of the dietary practices
Inventory of the dietary practices of participating patients and their potential interest in fasting or special diets by means of a self-administered survey completed by the patient at diagnosis before treatment. Determination of the proportions of patients who have already followed or respond favorably to the idea of fasting and/or a particular diet. The survey is semi-quantitative.
Measured: 1 to 15 days
Secondary outcomes (12)
Evaluate the nutritional status of patients before treatement with radiochemotherapy for non-small cell lung cancer located in the thorax.
Descriptive analysis of the nutritional status of the population before the start of radiochemotherapy.
Measured: 3 month
Evaluate the nutritional status of patients in the month following the radiochemotherapy for non-small cell lung cancer located in the thorax.
Descriptive analysis of the nutritional status of the population in the month following the end of radiochemotherapy.
Measured: 3 month
Evaluate the evolution of nutritional status in the population of the study
Descriptive analysis of the evolution (deterioration, stability, improvement) of the nutritional status of the population before the start of radiochemotherapy and in the month following the end of it.
Measured: 3 month
Evaluate the evolution of total cholesterol in the population.
Descriptive analysis of the evolution of the metabolic parameter total cholesterol (mmol/L) before the start of radiochemotherapy and in the month following the end of it.
Measured: 3 month
Evaluate the evolution of High Density Lipoprotein (HDL) in the population.
Descriptive analysis of the evolution of the metabolic parameter High Density Lipoprotein (HDL) (mmol/L) before the start of radiochemotherapy and in the month following the end of it.
Measured: 3 month
Evaluate the evolution of Low Density Lipoprotein (LDL) in the population.
Descriptive analysis of the evolution of the metabolic parameter Low Density Lipoprotein (LDL) (mmol/L) before the start of radiochemotherapy and in the month following the end of it.
Measured: 3 month
Evaluate the evolution of triglycerides in the population.
Descriptive analysis of the evolution of the metabolic parameter triglycerides (mmol/L) before the start of radiochemotherapy and in the month following the end of it.
Measured: 3 month
Evaluate the evolution of uricemia in the population.
Descriptive analysis of the evolution of the metabolic parameter uricemia (mmol/L) before the start of radiochemotherapy and in the month following the end of it.
Measured: 3 month
Evaluate the evolution of fasting glucose in the population.
Descriptive analysis of the evolution of the metabolic parameter fasting glucose (mmol/L) before the start of radiochemotherapy and in the month following the end of it.
Measured: 3 month
Evaluate the evolution of Glycated hemoglobin (HbA1C) in the population
Descriptive analysis of the evolution of the metabolic parameter Glycated hemoglobin (HbA1C) (%) before the start of radiochemotherapy and in the month following the end of it.
Measured: 3 month
Evaluate the evolution of the index homeostasis model assessment (HOMA) in the population
Descriptive analysis of the evolution of the index HOMA (no unit) before the start of radiochemotherapy and in the month following the end of it.
Measured: 3 month
Evaluate the evolution of Vitamin D in the population
Descriptive analysis of the evolution of the metabolic parameter vitamin D (ng/L) before the start of radiochemotherapy and in the month following the end of it.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine DURDUX, MD-PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068088
- Sponsor's protocol ID
- APHP230706
- Other IDs
- IDRCB 2023-A00329-36, 23.01988.000202
- Acronym
- LUNGDIET
- Status last verified
- Oct 2023
- First submitted
- 30 Aug 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Survey of Dietary Practices and Nutritional Status of Patients Treated With Radiochemotherapy for Non-small Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT06068088
- Acronym / sponsor ID
- LUNGDIET / APHP230706
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Radiochemotherapy, Fasting, Special diet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 5 Oct 2023 (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.
In recent years, fasting or the use of special diets (ketogenic, high protein, etc.), whether or not associated with food supplements, have increased substantially, particularly in oncology with the idea of improving for some of them, the tolerance of the proposed treatments, in particular emetogenic chemotherapy, or even to improve the prognosis. Although there are preclinical data on cell cultures and in rats, the clinical data supporting these practices are very fragmented, with few trials carried out and only including small cohorts, mainly in the context of breast cancers. It is therefore very difficult to respond objectively to patients asking the question of the merits of these changes in dietary practices in the management of their cancer.
The investigators want to carry out an inventory of the dietary practices of participating patients and their potential interest in fasting or special diets by means of a self-administered survey completed by the patient at diagnosis before treatment. This semi-quantitative self-administered survey (answers in never / sometimes / regularly / systematically) was developed by the nutrition and radiotherapy team of the Georges-Pompidou European Hospital because there was no validated medical questionnaire on fasting or the use of special diets in oncology
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Behavioral: Self-administered survey at hospitalParticipating patients from 5 radiotherapy center of AP-HP |
| Cohort B | – | Behavioral: Self-administered survey at hospital, Biological: Blood sample for nutritional assessment, Other: Consultation with nutritionist doctor and dieticianParticipating patients from the european hospital Georges-Pompidou |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is aimed at patients treated with radiochemotherapy for non-small cell lung cancer localized in thorax. The choice of this population is based on its frequency, its clinical homogeneity, the prospect of a curative treatment but with a clearly improvable prognosis and the absence of published data on the subject.
Key inclusion criteria (3 listed)
- Histologically documented inoperable stage III non-small cell lung carcinoma (no metastasis)
- Treatment with curative intent including thoracic radiotherapy and at least one cycle of concomitant chemotherapy
- Patient informed and having signed the consent
Key exclusion criteria (9 listed)
- Sequential radiochemotherapy
- Metastatic forms from the outset
- Ear, nose, and throat (ENT) or digestive pathologies interfering with normal oral nutrition
- Other concurrent or pre-existing cancer for less than 5 years at the diagnosis of bronchial cancer
- Patient under guardianship or curatorship
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 |
|---|---|---|
| Self-administered survey at hospitalSelf-administered survey on the food practices of the patient Completion before the beginning of chemoradiotherapy | Behavioural | Cohort A, Cohort B |
| Blood sample for nutritional assessment15 ml of blood sampled during nutritional examination before the beginning and during the month following the end of chemoradiotherapy | Biological | Cohort B |
| Consultation with nutritionist doctor and dieticianBefore the beginning and during the month following the end of chemoradiotherapy Consultation of approximatively one hour | Other | Cohort B |
Primary outcome
Inventory of the dietary practices
Time frame: 1 to 15 days
Inventory of the dietary practices of participating patients and their potential interest in fasting or special diets by means of a self-administered survey completed by the patient at diagnosis before treatment. Determination of the proportions of patients who have already followed or respond favorably to the idea of fasting and/or a particular diet. The survey is semi-quantitative.
12 secondary outcomes
Evaluate the nutritional status of patients before treatement with radiochemotherapy for non-small cell lung cancer located in the thorax.
Time frame: 3 month
Evaluate the nutritional status of patients in the month following the radiochemotherapy for non-small cell lung cancer located in the thorax.
Time frame: 3 month
Evaluate the evolution of nutritional status in the population of the study
Time frame: 3 month
Evaluate the evolution of total cholesterol in the population.
Time frame: 3 month
Evaluate the evolution of High Density Lipoprotein (HDL) in the population.
Time frame: 3 month
Evaluate the evolution of Low Density Lipoprotein (LDL) in the population.
Time frame: 3 month
Evaluate the evolution of triglycerides in the population.
Time frame: 3 month
Evaluate the evolution of uricemia in the population.
Time frame: 3 month
Evaluate the evolution of fasting glucose in the population.
Time frame: 3 month
Evaluate the evolution of Glycated hemoglobin (HbA1C) in the population
Time frame: 3 month
Evaluate the evolution of the index homeostasis model assessment (HOMA) in the population
Time frame: 3 month
Evaluate the evolution of Vitamin D in the population
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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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.
Catherine DURDUX, MD-PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Assistance Publique - Hôpitaux de Paris.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annie BERGERA (33 (0)144841724, gestion-locale.drc@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory of the dietary practices (time frame: 1 to 15 days). 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 5 Oct 2023.