Nutrition in Gastroenteropancreatic Neuroendocrine Tumor

Gastroenteropancreatic Neuroendocrine Tumor Clinical Trial

— NUTRIGETNE  

Official title:

Nutritional Status of Patients With Gastroenteropancreatic Neuroendocrine Tumors in Spain: NUTRIGETNE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04986085
• Other study ID #: GETNE-S2109
• Status: Recruiting
• Start date: February 24, 2021
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Grupo Espanol de Tumores Neuroendocrinos
• Contact: A responsible person designated by the sponsor
• Phone: +34 93 434 44 12
• Email: investigacion[@]mfar.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2023
• Est. primary completion date: July 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroenteropancreatic Neuroendocrine Tumor
• Intestinal Neoplasms
• Neuroendocrine Tumors
• Pancreatic Neoplasms
• Stomach Neoplasms

Locations

Country	Name	City	State
Spain	Hospital Universitario Vall d´Hebron	Barcelona
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	Hospital Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Universitario Dr. Josep Trueta	Gerona
Spain	Hospital Universitario de Cabueñes	Gijón
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Clínico San Carlos	Madrid
Spain	Hospital Universitario la Paz	Madrid
Spain	Hospital Universitario la Princesa	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo
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	Institut Valencià d'Oncologia (IVO)	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Espanol de Tumores Neuroendocrinos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of malnutrition in GEP NET	Percentage of GEP NET patients suffering from malnutrition in Spain.	Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Primary	Risk of malnutrition in GEP NET	Percentage of GEP NET patients at risk of suffering from malnutrition in Spain.	Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Secondary	Body mass index	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	Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Secondary	Body fat	Body fat mass calculated by bioimpedance	Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Secondary	Body muscle mass	Body muscle mass calculated by bioimpedance	Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Secondary	Nutritional Risk Screening (NRS) rates	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).	Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Secondary	Subjective Global Assessment (SGA) rates	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)	Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)