Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2023-A00329-36 | Other Identifier | Agence nationale de sécurité du médicament et des produits de santé | |
| 23.01988.000202 | Other Identifier | Commission Nationale des Recherche Impliquant la Personne Humaine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Participating patients from 5 radiotherapy center of AP-HP |
| |
| Cohort B | Participating patients from the european hospital Georges-Pompidou |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-administered survey at hospital | Behavioral | Self-administered survey on the food practices of the patient Completion before the beginning of chemoradiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 month |
| Evaluate the nutritional status of patients in the month following the radiochemotherapy for non-small cell lung cancer located in the thorax. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annie BERGERA | Contact | 33 (0)144841724 | gestion-locale.drc@aphp.fr | |
| Natacha NOHILE | Contact | 33(0)156095982 | natacha.nohile@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Catherine DURDUX, MD-PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
Not provided
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision.
Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.
Processing of shared data must comply with European General Data Protection Regulation (GDPR).
Not provided
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D015596 | Nutrition Assessment |
| D012017 | Referral and Consultation |
| D064686 | Nutritionists |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
| Blood sample for nutritional assessment | Biological | 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 dietician | Other | Before the beginning and during the month following the end of chemoradiotherapy Consultation of approximatively one hour |
|
Descriptive analysis of the nutritional status of the population in the month following the end of radiochemotherapy. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 3 month |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |