Dietary Practices and Locally Advanced Lung Cancer (LUNGDIET)

Not yet recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Behavioral: Self-administered survey at hospital; Biological: Blood sample for nutritional assessment; Other: Consultation with nutritionist doctor and dietician

• Registration Number: NCT06068088
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-30
• Status Verified: 2023-10
• Study Start: 2023-10
• Study First Submitted QC: 2023-10-03
• Last Update Submitted: 2023-10-03
• Study First Posted: 2023-10-05
• Last Update Posted: 2023-10-05
• Primary Completion: 2024-12
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B	Blood sample for nutritional assessment	Participating patients from the european hospital Georges-Pompidou
Cohort A	Self-administered survey at hospital	Participating patients from 5 radiotherapy center of AP-HP
Cohort B	Self-administered survey at hospital	Participating patients from the european hospital Georges-Pompidou
Cohort B	Consultation with nutritionist doctor and dietician	Participating patients from the european hospital Georges-Pompidou

Primary Outcome Measures

Name	Time	Method
Inventory of the dietary practices	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate the nutritional status of patients before treatement with radiochemotherapy for non-small cell lung cancer located in the thorax.	3 month	Descriptive analysis of the nutritional status of the population before the start of radiochemotherapy.
Evaluate the evolution of Low Density Lipoprotein (LDL) in the population.	3 month	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.
Evaluate the evolution of Glycated hemoglobin (HbA1C) in the population	3 month	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.
Evaluate the evolution of the index homeostasis model assessment (HOMA) in the population	3 month	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.
Evaluate the nutritional status of patients in the month following the radiochemotherapy for non-small cell lung cancer located in the thorax.	3 month	Descriptive analysis of the nutritional status of the population in the month following the end of radiochemotherapy.
Evaluate the evolution of total cholesterol in the population.	3 month	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.
Evaluate the evolution of High Density Lipoprotein (HDL) in the population.	3 month	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.
Evaluate the evolution of triglycerides in the population.	3 month	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.
Evaluate the evolution of fasting glucose in the population.	3 month	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.
Evaluate the evolution of nutritional status in the population of the study	3 month	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.
Evaluate the evolution of uricemia in the population.	3 month	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.
Evaluate the evolution of Vitamin D in the population	3 month	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.