Dietary Practices and Locally Advanced Lung Cancer (LUNGDIET)

Carcinoma, Non-Small-Cell Lung Clinical Trial

— LUNGDIET  

Official title:

Preliminary Survey of Dietary Practices and Nutritional Status of Patients Treated With Radiochemotherapy for Non-small Cell Lung Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06068088
• Other study ID #: APHP230706
• Secondary ID: IDRCB 2023-A0032
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: February 2025

Study information

• Verified date: October 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Annie BERGERA
• Phone: 33 (0)144841724
• Email: gestion-locale.drc[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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