Nutrition in Gastroenteropancreatic Neuroendocrine Tumor

Completed

Conditions: Gastroenteropancreatic Neuroendocrine Tumor

Registration Number: NCT04986085

Lead Sponsor: Grupo Espanol de Tumores Neuroendocrinos

Brief Summary: It is well known that the prevalence of malnutrition or risk of malnutrition in cancer patients is high, as well as its impact on different parameters such as hospitalization, survival or response to certain treatments. In patients with gastroenteropancreatic (GEP) neuroendocrine tumors (NET), due to their heterogeneity and longer survival, it is expected that the prevalence of malnutrition is probably underdiagnosed, as well as the existence of a negative impact on different parameters (quality of life, survival). So far, the studies carried out on nutrition and NET are very scarce and none has been carried out so far in Spain.

Before being able to carry out nutritional intervention studies on these patients, it is necessary to know the reality of the nutritional status of patients with NETs in Spain. The main motivation for the NUTRIGETNE study is to evaluate the epidemiological status of nutrition in NETs in the spanish population. In addition to know the epidemiological picture, it is intended to study the nutritional status from different points of view: analytical, clinical, anthropometric, etc. Besides, the study of nutritional status will allow us to closely monitor the patients who have a higher risk of malnutrition and to propose early interventions for those, as well as the impact of their nutritional status on different parameters: survival, hospitalization, quality of life or responses to the treatments.

NUTRIGETNE is a cross-sectional, open and multicenter study in which the nutritional status of patients with GEP NET in Spain will be evaluated.

Detailed Description: NUTRIGETNE is a cross-sectional, open and multicenter study in which the nutritional status of patients with GEP NET in Spain will be evaluated. It is planned to include 400 GEP NET patients. Patients will be included consecutively when visiting the corresponding health centers for outpatient visits or hospitalization.

The study comprises 3 stages with a total duration of 10 to 40 days for the participation of each subject in the study:

Screening visit, First day (day 0): The initial screening will take place on the first day the patient visits the hospital. The inclusion and exclusion criteria will be reviewed to assess the eligibility of the patient. The implications of the study will be explained to the patient and the informed consent will be signed.

Visit for assessment of nutritional status (days 0-10): taking a medical history, complete physical examination including anthropometry, bioelectrical impedance (BIA) and dynamometry, as well as laboratory analysis. The evaluation of the nutritional status will be carried out by a registered nutritionist, specialized nurse or specialist doctor (variable depending on the characteristics of the center).

Data collection (day 10-40): collection of analytical, anthropometric, BIA, dynamometry and clinical results and introduction into the electronic case report form (eCRF).

After the end of recruitment and database lock, all data will be subsequently analyzed and presented when applicable through study reports and scientific communications.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 399

Inclusion Criteria

Patients diagnosed with a gastroenteropancreatic neuroendocrine tumor by histopathological study.
Legally capable patients ≥ 18 and ≤ 80 years of age.
Patients who have signed the informed consent for this study as specified in section 10.3.
Patients in active treatment: active treatment is considered to be those patients in an advanced stage and in any type of medical treatment (somatostatin analogues, molecular therapies, chemotherapy, radionuclides...), or locoregional therapies.

Note: Decision was taken to treat the patient with an specific treatment prior and independently of patient inclusion in this non interventional study.

Exclusion Criteria

Patients <18 or > 80 years of age.
Female patients that are currently pregnant.
Patients with a gastroenteropancreatic neuroendocrine tumor lacking an histopathological diagnosis.
Patients in palliative treatment or terminal stage.
Patients who have not signed the informed consent or any situation or condition that compromises the giving of patient voluntary informed consent.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Malnutrition in GEP NET	Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)	Percentage of GEP NET patients suffering from malnutrition in Spain according to the Global Leadership Initiative on Malnutrition (GLIM), which was convened by several of the major global clinical nutrition societies. Malnutrition diagnosis is based on three phenotypic criteria (non-volitional weight loss, low body mass index, and reduced muscle mass) and two etiologic criteria (reduced food intake or assimilation, and inflammation or disease burden). Patients having one or more phenotypic and etiologic criteria are considered malnourished.
Risk of Malnutrition in GEP NET	Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)	Percentage of GEP NET patients at risk of suffering from malnutrition in Spain according to Malnutrition Universal Screening Tool (MUST). Three independent criteria are used by MUST to determine the overall risk for malnutrition: current weight status using BMI, unintentional weight loss, and acute disease effect.

Secondary Outcome Measures

Name	Time	Method
Phase Angle	Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)	Body muscle mass calculated by bioimpedance and measured by Phase Angle. Here we report the phase angle, a marker of muscle mass and function, measured in degrees. Higher degrees of phase angle indicates greater cell integrity and function, reflecting healthier and more robust muscles.
Nutritional Risk Screening (NRS) Rates	Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)	Scale to evaluate the malnutrition in adult patients. It is based in the assessment of BMI, weight loss in the last 3-6 months and acute disease effects. The score ranges from 0 (low malnutrition risk to 6 (high malnutrition risk).
Subjective Global Assessment (SGA) Rates	Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)	Score to measure risk malnutrition in adult patients based on patient history and physical examination alone. The score has 3 levels: A (low malnutrition risk) to C (high malnutrition risk)
Body Mass Index	Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)	Body mass index (BMI) is defined as a a measure of body fat based on height and weight that applies to adult men and women
Body Fat	Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)	Body fat mass calculated by bioimpedance

Trial Locations

Locations (16): Hospital Universitario Virgen de la Arrixaca
🇪🇸
El Palmar, Murcia, Spain
Hospital Universitario de Cabueñes
🇪🇸
Gijón, Spain
Hospital Universitario la Princesa
🇪🇸
Madrid, Spain
Hospital Universitario Dr. Josep Trueta
🇪🇸
Gerona, Spain
Hospital Universitario Vall d´Hebron
🇪🇸
Barcelona, Spain
Hospital Universitario Reina Sofia
🇪🇸
Córdoba, Spain
Hospital Universitario Ramón y Cajal
🇪🇸
Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸
Madrid, Spain
Hospital Universitario Central de Asturias
🇪🇸
Oviedo, Spain
Hospital Universitario Miguel Servet
🇪🇸
Zaragoza, Spain
Institut Valencià d'Oncologia (IVO)
🇪🇸
Valencia, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸
Santander, Spain
Hospital Clínico Universitario de Santiago
🇪🇸
Santiago De Compostela, Spain
Hospital Universitari i Poliècnic la Fe
🇪🇸
Valencia, Spain
Hospital Universitario Clínico San Carlos
🇪🇸
Madrid, Spain
Hospital Universitario la Paz
🇪🇸
Madrid, Spain