Dietary Practices and Locally Advanced Lung Cancer (LUNGDIET)

NCT ID: NCT06068088

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2025-02-28

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

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A

Participating patients from 5 radiotherapy center of AP-HP

Self-administered survey at hospital

Intervention Type: BEHAVIORAL

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

Self-administered survey at hospital

Intervention Type: BEHAVIORAL

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

Blood sample for nutritional assessment

Intervention Type: BIOLOGICAL

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

Consultation with nutritionist doctor and dietician

Intervention Type: OTHER

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

Interventions

Self-administered survey at hospital

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BIOLOGICAL

Consultation with nutritionist doctor and dietician

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine DURDUX, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Central Contacts

Annie BERGERA

Role: CONTACT

gestion-locale.drc@aphp.fr

33 (0)144841724

Natacha NOHILE

Role: CONTACT

natacha.nohile@aphp.fr

33(0)156095982

Other Identifiers

IDRCB 2023-A00329-36

Identifier Type: OTHER

Identifier Source: secondary_id

23.01988.000202

Identifier Type: OTHER

Identifier Source: secondary_id

APHP230706

Identifier Type: -

Identifier Source: org_study_id