Clinical trial NCT06068088: Dietary Practices and Locally Advanced Lung Cancer (LUNGDIET)
Official title: Preliminary Survey of Dietary Practices and Nutritional Status of Patients Treated With Radiochemotherapy for Non-small Cell Lung Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Radiochemotherapy
Fasting
Special diet
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Inventory of the dietary practices
timeFrame: 1 to 15 days
Secondary outcomes:
measure: Evaluate the nutritional status of patients before treatement with radiochemotherapy for non-small cell lung cancer located in the thorax.
timeFrame: 3 month
measure: Evaluate the nutritional status of patients in the month following the radiochemotherapy for non-small cell lung cancer located in the thorax.
timeFrame: 3 month
measure: Evaluate the evolution of nutritional status in the population of the study
timeFrame: 3 month
measure: Evaluate the evolution of total cholesterol in the population.
timeFrame: 3 month
measure: Evaluate the evolution of High Density Lipoprotein (HDL) in the population.
timeFrame: 3 month
measure: Evaluate the evolution of Low Density Lipoprotein (LDL) in the population.
timeFrame: 3 month
measure: Evaluate the evolution of triglycerides in the population.
timeFrame: 3 month
measure: Evaluate the evolution of uricemia in the population.
timeFrame: 3 month
measure: Evaluate the evolution of fasting glucose in the population.
timeFrame: 3 month
measure: Evaluate the evolution of Glycated hemoglobin (HbA1C) in the population
timeFrame: 3 month
measure: Evaluate the evolution of the index homeostasis model assessment (HOMA) in the population
timeFrame: 3 month
measure: Evaluate the evolution of Vitamin D in the population
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Catherine DURDUX, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: