Clinical trial NCT04986085: Nutrition in Gastroenteropancreatic Neuroendocrine Tumor
Official title: Nutritional Status of Patients With Gastroenteropancreatic Neuroendocrine Tumors in Spain: NUTRIGETNE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteropancreatic Neuroendocrine Tumor
Keywords: GEP NET
Neuroendocrine tumor
Nutritional status
Lead sponsor: Grupo Espanol de Tumores Neuroendocrinos
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with gastroenteropancreatic neuroendocrine tumors diagnosed histologically that are on active treatment for the disease in Spain

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Malnutrition in GEP NET
timeFrame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
measure: Risk of Malnutrition in GEP NET
timeFrame: 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:
measure: Body Mass Index
timeFrame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
measure: Body Fat
timeFrame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
measure: Phase Angle
timeFrame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
measure: Nutritional Risk Screening (NRS) Rates
timeFrame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
measure: Subjective Global Assessment (SGA) Rates
timeFrame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Other outcomes:
Locations:
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
state: Murcia
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d´Hebron
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Gerona
country: Spain
facility: Hospital Universitario Dr. Josep Trueta
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
city: Madrid
country: Spain
facility: Hospital Universitario la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario la Paz
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
city: Valencia
country: Spain
facility: Hospital Universitari i Poliècnic la Fe
city: Valencia
country: Spain
facility: Institut Valencià d'Oncologia (IVO)
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Hospital Universitario La Fe
name: María Isabel del Olmo García, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Fe
name: María Argente Pla, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: