Dietary Practices and Locally Advanced Lung Cancer (LUNGDIET)

NCT06068088 | Unknown

• 3 other identifiers: APHP230706IDRCB 2023-A00329-3623.01988.000202
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Keywords

Radiochemotherapy; Fasting; Special diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Evaluate the nutritional status of patients before treatement with radiochemotherapy for non-small cell lung cancer located in the thorax.

  3 month

• Evaluate the nutritional status of patients in the month following the radiochemotherapy for non-small cell lung cancer located in the thorax.

  3 month

• Evaluate the evolution of nutritional status in the population of the study

  3 month

• Evaluate the evolution of total cholesterol in the population.

  3 month

• Evaluate the evolution of High Density Lipoprotein (HDL) in the population.

  3 month

Study Arms (2)

Cohort A

Participating patients from 5 radiotherapy center of AP-HP

Behavioral: Self-administered survey at hospital

Cohort B

Participating patients from the european hospital Georges-Pompidou

Behavioral: Self-administered survey at hospital; Biological: Blood sample for nutritional assessment; Other: Consultation with nutritionist doctor and dietician

Interventions

Self-administered survey at hospital BEHAVIORAL

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

Cohort A; Cohort B

Blood sample for nutritional assessment BIOLOGICAL

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

Cohort B

Consultation with nutritionist doctor and dietician OTHER

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

Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Fasting

Interventions

Blood Specimen Collection; Nutrition Assessment; Referral and Consultation; Nutritionists

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Professional Practice; Organization and Administration; Health Services Administration; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Catherine DURDUX, MD-PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annie BERGERA

CONTACT

33 (0)144841724; gestion-locale.drc@aphp.fr

Natacha NOHILE

CONTACT

33(0)156095982; natacha.nohile@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: October 5, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).