Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Participating patients from 5 radiotherapy center of AP-HP

Participating patients from the european hospital Georges-Pompidou

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

Self-administered survey at hospital

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

Blood sample for nutritional assessment

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

Consultation with nutritionist doctor and dietician

Annie BERGERA

Natacha NOHILE

Catherine DURDUX, MD-PhD

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

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

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

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.

Descriptive analysis of the nutritional status of the population before the start of radiochemotherapy.

Descriptive analysis of the nutritional status of the population in the month following the end of radiochemotherapy.

Descriptive 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.

Descriptive 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.

Descriptive 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.

Descriptive 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.

Descriptive 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.

Descriptive 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.

Descriptive 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.

Descriptive 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.

Descriptive analysis of the evolution of the index HOMA (no unit) before the start of radiochemotherapy and in the month following the end of it.

Descriptive 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.

Assistance Publique - Hôpitaux de Paris

Symptoms and General Pathology

Blood and Lymph Conditions

Body Weight

Hematologic Neoplasms

Hematologic Diseases

Special diet with taste, energy-and protein content adjusted according to previous finding

Tate and energy content adjusted with spices to obtain maximal intake

Special diet

Jens Rikardt Andersen, MD,MPA

Major weight loss and taste changes are well documented in patients with hematological cancer during chemotherapy. It has previously been documented, that such patients have preferences for much umami, a little sweet, sour and salt, and no bitter. The purpose of the study was to convert these results into real diets. Patients participated in two sensory pilot studies (n=10), where dishes were tested for preferences before and after chemotherapy. From these results four dishes were selected and tested on 32 patients in 30 days in a cross-over design. The diets resulted in a beneficial and statistical significant difference in weight development (p= 0.0008), with 1.2 ± 1.9 kg (+2%) in the intervention period and -2.8 ± 5.2 kg (-4%) in the control period. This difference persisted after sensitivity analysis (± 10%) p= 0.005. However, the nutritional intake was still low in both periods, and the treatment with cytarabin turned out to be a major confounder as dosage was significantly higher in the control period.

The study was approved by the regional scientific ethical committee, and was registered in ClinicalTrial.gov NTC no............

Patients were selected consecutively with acute and chronic leukemia and lymphoma, Hodg-kin's lymphoma, and Non-Hodgkin's lymphoma in treatment with chemotherapy.

Eligible patients were aged \>18 years, and only patients who were able to com-municate and understand written and oral information and receive food orally were included. The special diets were developed at the Central Kitchen at Rigshospitalet Initially, two single blinded pilot studies of five patients were performed, with the same inclusion and exclusion criteria as the main study. In the first study patients tested 17 dishes with a taste-mix of dominating umami, a little sweet, sour and salt, and no bitter. In the second round six dishes were selected based on the results from the first round. All dishes had a high energy-density, with a protein content of at least 5 g/100 g. Every dish was tested both before and after chemotherapy. Patients rated acceptability on 9-point scales.

The clinical controlled cross-over design with two periods of four weeks, intervention and control, tested four dishes selected after the second pilot study. 32 patients were included in that trial, and they started with their habitual diet as control and then switched to recommendation of introduction of the four dishes selected.

The patients registered their weight every time they were at the hospital. During the intervention period the patients received a recipe booklet with the four dishes and a noted every time they ingested one of these. Compliance measurements were based on this registration. Patients had access to the dishes when in-patients, but they did their own cooking at home. It was possible to buy the similar dishes as pre-prepared meals in the supermarkets. The dishes in the final study were: Chili con Carne, Chicken in Curry, Curry Soup and Pasta Carbonara with added curry.

Data were analyzed with R (version 2.15.3). In histograms used to show the degree of acceptability for the dishes in the pilot studies, answers above 5 were graded as high grade of acceptance. To present descriptive statistics, the results were expressed as mean ± standard deviation (SD), median (interquartile range (IQR)) and range. As the data did not show a normal distribution, Wilcoxon rang-sum tests (paired and unpaired) were used. Analyses were carried out both according to intention-to- treat (ITT) and per-protocol (PP) principles. As many of the data sampled, especially the subjective ones, sensitivity analysis (± 10% correction of the results) were performed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dietary Practices and Locally Advanced Lung Cancer (LUNGDIET)	NCT06068088	Carcinoma, Non-...	Self-administer... Blood sample fo... Consultation wi...	18 Years -	Assistance Publique - Hôpitaux de Paris
The Effect of Special Diets in Hematological Cancer Patients	NCT02880709	Hematological M...	Special diet	18 Years -	University of Copenhagen

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