Nutrition in Gastroenteropancreatic Neuroendocrine Tumor

NCT04986085 | Completed Results DMC

• 1 other identifier: GETNE-S2109
• Study Type: observational
• Target: 399
• Locations: 1 country
• Sites: 16

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.

Conditions

Gastroenteropancreatic Neuroendocrine Tumor

Keywords

GEP NET; Neuroendocrine tumor; Nutritional status

Outcome Measures

Primary Outcomes (2)

• Prevalence of Malnutrition in GEP NET

  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.

  Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)

• Risk of Malnutrition in GEP NET

  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.

  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 Outcomes (5)

• 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 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)

• 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)

• 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)

• 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)

Study Arms (1)

GEP NET

GEP NET patients in Spain

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with gastroenteropancreatic neuroendocrine tumors diagnosed histologically that are on active treatment for the disease in Spain

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grupo Espanol de Tumores Neuroendocrinos: lead

Study Sites (16)

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Universitario Vall d´Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario de Cabueñes

Gijón, 33394, Spain

Location

Hospital Universitario Dr. Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitario la Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario la Paz

Madrid, 28046, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Clínico Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

Hospital Universitari i Poliècnic la Fe

Valencia, 40026, Spain

Location

Institut Valencià d'Oncologia (IVO)

Valencia, 46009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor; Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: A responsible Person Designated by the Sponsor
• Organization: Grupo Español de Tumores Neuroendocrinos y Endocrinos

investigacion@mfar.net

0034934344412

Study Officials

• María Isabel del Olmo García, M.D. Ph.D.

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

• María Argente Pla, M.D. Ph.D.

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: August 2, 2021
• Study Start: February 24, 2021
• Primary Completion: January 23, 2024
• Study Completion: February 23, 2024
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (16)