Nutrition in Gastroenteropancreatic Neuroendocrine Tumor (NUTRIGETNE)

November 16, 2022 updated by: Grupo Espanol de Tumores Neuroendocrinos

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

Recruiting

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 (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall D´Hebron
        • Contact:
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofía
        • Contact:
      • Gerona, Spain, 17007
        • Recruiting
        • Hospital Universitario Dr. Josep Trueta
        • Contact:
      • Gijón, Spain, 33394
        • Recruiting
        • Hospital Universitario de Cabueñes
        • Contact:
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario La Princesa
        • Contact:
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Clinico San Carlos
        • Contact:
      • Oviedo, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
      • Santiago De Compostela, Spain, 15706
        • Recruiting
        • Hospital Clinico Universitario de Santiago
        • Contact:
      • Valencia, Spain, 40026
        • Recruiting
        • Hospital Universitari i Poliècnic la Fe
        • Contact:
        • Principal Investigator:
          • Principal investigator selected by the sponsor, M.D. Ph.D.
      • Valencia, Spain, 46009
        • Recruiting
        • Institut Valencià d'Oncologia (IVO)
        • Contact:
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Universitario Virgen de la Arrixaca
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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).
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
Time Frame: 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)
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2021

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

December 1, 2023

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)

November 17, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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