Dietary Practices and Locally Advanced Lung Cancer (LUNGDIET) (LUNGDIET)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Behavioral: Self-administered survey at hospital; Biological: Blood sample for nutritional assessment; Other: Consultation with nutritionist doctor and dietician

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Annie BERGERA; Phone Number: 33 (0)144841724; Email: gestion-locale.drc@aphp.fr
• Study Contact Backup: Name: Natacha NOHILE; Phone Number: 33(0)156095982; Email: natacha.nohile@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; Participating patients from 5 radiotherapy center of AP-HP	Behavioral: Self-administered survey at hospital; Self-administered survey on the food practices of the patient Completion before the beginning of chemoradiotherapy
Cohort B; Participating patients from the european hospital Georges-Pompidou	Behavioral: Self-administered survey at hospital; Self-administered survey on the food practices of the patient Completion before the beginning of chemoradiotherapy; Biological: Blood sample for nutritional assessment; 15 ml of blood sampled during nutritional examination before the beginning and during the month following the end of chemoradiotherapy; Other: Consultation with nutritionist doctor and dietician; Before the beginning and during the month following the end of chemoradiotherapy Consultation of approximatively one hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Catherine DURDUX, MD-PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Fasting; Radiochemotherapy; Special diet
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma
• Other Study ID Numbers: APHP230706; 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)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
• IPD Sharing Time Frame: Two years after the last publication

IPD Sharing Access Criteria

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).

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No