Dietary Practices and Locally Advanced Lung Cancer (LUNGDIET)

Trial Title: Dietary Practices and Locally Advanced Lung Cancer (LUNGDIET)

NCT ID: NCT06068088

Condition: Carcinoma, Non-Small-Cell Lung

Conditions: Official terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Radiochemotherapy
Fasting
Special diet

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Behavioral
Intervention name: Self-administered survey at hospital
Description: Self-administered survey on the food practices of the patient Completion before the beginning of chemoradiotherapy
Arm group label: Cohort A
Arm group label: Cohort B

Intervention type: Biological
Intervention name: Blood sample for nutritional assessment
Description: 15 ml of blood sampled during nutritional examination before the beginning and during the month following the end of chemoradiotherapy
Arm group label: Cohort B

Intervention type: Other
Intervention name: Consultation with nutritionist doctor and dietician
Description: Before the beginning and during the month following the end of chemoradiotherapy Consultation of approximatively one hour
Arm group label: Cohort B

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

Criteria for eligibility:

Study pop:
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.

Sampling method: Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: October 2023

Completion date: February 2025

Lead sponsor:
Agency: Assistance Publique - Hôpitaux de Paris
Agency class: Other

Source: Assistance Publique - Hôpitaux de Paris

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06068088