CompletedNot Applicable

Nutrition in Gastroenteropancreatic Neuroendocrine Tumor

Spain399 participantsStarted 2021-02-24

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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)

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)

Trial details

NCT IDNCT04986085

SponsorGrupo Espanol de Tumores Neuroendocrinos

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-23

Results submitted2024-11-25

View on ClinicalTrials.gov More Gastroenteropancreatic Neuroendocrine Tumor trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)

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)