Nutrition in Gastroenteropancreatic Neuroendocrine Tumor (NUTRIGETNE)

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

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.

Study Overview

• Status: Completed
• Conditions: Gastroenteropancreatic Neuroendocrine Tumor

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.

• Study Type: Observational
• Enrollment (Actual): 399

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d´Hebron
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Gerona, Spain, 17007
    • Hospital Universitario Dr. Josep Trueta
  • Gijón, Spain, 33394
    • Hospital Universitario de Cabueñes
  • Madrid, Spain, 28006
    • Hospital Universitario La Princesa
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos
  • Oviedo, Spain, 33011
    • Hospital Universitario Central de Asturias
  • Santander, Spain, 39008
    • Hospital Universitario Marqués de Valdecilla
  • Santiago De Compostela, Spain, 15706
    • Hospital Clinico Universitario de Santiago
  • Valencia, Spain, 40026
    • Hospital Universitari i Poliècnic la Fe
  • Valencia, Spain, 46009
    • Institut Valencià d'Oncologia (IVO)
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Universitario Virgen de La Arrixaca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
GEP NET; GEP NET patients in Spain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Phase Angle	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.	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	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)
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)

Collaborators and Investigators

• Sponsor: Grupo Espanol de Tumores Neuroendocrinos
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): January 23, 2024
• Study Completion (Actual): February 23, 2024

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Nutritional status; Neuroendocrine tumor; GEP NET
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Stomach Neoplasms; Pancreatic Neoplasms; Neuroendocrine Tumors; Intestinal Neoplasms
• Other Study ID Numbers: GETNE-S2109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No