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Dietary Practices and Locally Advanced Lung Cancer (LUNGDIET)

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06068088
Acronym
LUNGDIET
Enrollment
120
Registered
2023-10-05
Start date
2023-10-31
Completion date
2025-02-28
Last updated
2023-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Radiochemotherapy, Fasting, Special diet

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

Interventions

BEHAVIORALSelf-administered survey at hospital

Self-administered survey on the food practices of the patient Completion before the beginning of chemoradiotherapy

BIOLOGICALBlood sample for nutritional assessment

15 ml of blood sampled during nutritional examination before the beginning and during the month following the end of chemoradiotherapy

OTHERConsultation with nutritionist doctor and dietician

Before the beginning and during the month following the end of chemoradiotherapy Consultation of approximatively one hour

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Inventory of the dietary practices1 to 15 daysInventory 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

MeasureTime frameDescription
Evaluate the nutritional status of patients in the month following the radiochemotherapy for non-small cell lung cancer located in the thorax.3 monthDescriptive analysis of the nutritional status of the population in the month following the end of radiochemotherapy.
Evaluate the evolution of nutritional status in the population of the study3 monthDescriptive 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 total cholesterol in the population.3 monthDescriptive 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 monthDescriptive 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 Low Density Lipoprotein (LDL) in the population.3 monthDescriptive 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 nutritional status of patients before treatement with radiochemotherapy for non-small cell lung cancer located in the thorax.3 monthDescriptive analysis of the nutritional status of the population before the start of radiochemotherapy.
Evaluate the evolution of uricemia in the population.3 monthDescriptive 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 fasting glucose in the population.3 monthDescriptive 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 Glycated hemoglobin (HbA1C) in the population3 monthDescriptive 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 population3 monthDescriptive 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 evolution of Vitamin D in the population3 monthDescriptive 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.
Evaluate the evolution of triglycerides in the population.3 monthDescriptive 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.

Contacts

Primary ContactAnnie BERGERA
gestion-locale.drc@aphp.fr33 (0)144841724
Backup ContactNatacha NOHILE
natacha.nohile@aphp.fr33(0)156095982

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026