Nutrition in Gastroenteropancreatic Neuroendocrine Tumor

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04986085

Acronym

NUTRIGETNE

Enrollment

399

Registered

2021-08-02

Start date

2021-02-24

Completion date

2024-02-23

Last updated

2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroenteropancreatic Neuroendocrine Tumor

Keywords

GEP NET, Neuroendocrine tumor, Nutritional status

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of Malnutrition in GEP NET	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 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.
Risk of Malnutrition in GEP NET	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 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.

Secondary

Measure	Time frame	Description
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)	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.
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 mass index (BMI) is defined as a a measure of body fat based on height and weight that applies to adult men and women
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)	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)
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)	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).
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)	Body fat mass calculated by bioimpedance

Countries

Spain

Participant flow

Participants by arm

Arm	Count
GEP NET GEP NET patients in Spain	399
Total	399

Baseline characteristics

Characteristic	GEP NET
Age, Continuous	62 years
Eastern Cooperative Oncology Group performance status (ECOG-PS) Score 0	213 Participants
Eastern Cooperative Oncology Group performance status (ECOG-PS) Score 1	125 Participants
Eastern Cooperative Oncology Group performance status (ECOG-PS) Score ≥ 2	20 Participants
Eastern Cooperative Oncology Group performance status (ECOG-PS) Score Unknown	41 Participants
Functionality Functioning	98 Participants
Functionality Not functioning	295 Participants
Functionality Unknown	6 Participants
Metastasis at inclusion 0	15 Participants
Metastasis at inclusion 1	227 Participants
Metastasis at inclusion ≥ 2	157 Participants
Most common sites of metastasis Liver Metastasis present	332 Participants
Most common sites of metastasis Liver No metastasis	67 Participants
Most common sites of metastasis Lung Metastasis present	28 Participants
Most common sites of metastasis Lung No metastasis	371 Participants
Most common sites of metastasis Lymph nodes Metastasis present	86 Participants
Most common sites of metastasis Lymph nodes No metastasis	313 Participants
Most common sites of metastasis Peritoneum Metastasis present	55 Participants
Most common sites of metastasis Peritoneum No metastasis	344 Participants
Previous lines of treatment 1	217 Participants
Previous lines of treatment 2	92 Participants
Previous lines of treatment ≥ 2	90 Participants
Primary tumor location Colorectal	18 Participants
Primary tumor location Gastric	10 Participants
Primary tumor location Other / Unknown	27 Participants
Primary tumor location Pancreas	167 Participants
Primary tumor location Small intestine	177 Participants
Race/Ethnicity, Customized African	6 Participants
Race/Ethnicity, Customized Caucasian	380 Participants
Race/Ethnicity, Customized Hispanic or latino	13 Participants
Region of Enrollment Spain	399 participants
Sex: Female, Male Female	171 Participants
Sex: Female, Male Male	228 Participants
Tumor Differentiation Carcinomas (NEC)	28 Participants
Tumor Differentiation Tumors (NET)	361 Participants
Tumor Differentiation Unknown	10 Participants
Tumor grade; World Health Organization (WHO) Grade 1	147 Participants
Tumor grade; World Health Organization (WHO) Grade 2	197 Participants
Tumor grade; World Health Organization (WHO) Grade 3	50 Participants
Tumor grade; World Health Organization (WHO) Unknown	5 Participants
Type of previous lines Chemotherapy Not received this previous treatment	319 Participants
Type of previous lines Chemotherapy Received this previous treatment	80 Participants
Type of previous lines Clinical trial Not received this previous treatment	357 Participants
Type of previous lines Clinical trial Received this previous treatment	42 Participants
Type of previous lines Immunotherapy Not received this previous treatment	392 Participants
Type of previous lines Immunotherapy Received this previous treatment	7 Participants
Type of previous lines Others Not received this previous treatment	393 Participants
Type of previous lines Others Received this previous treatment	6 Participants
Type of previous lines Peptide receptor radiotherapy (PRRT) Not received this previous treatment	290 Participants
Type of previous lines Peptide receptor radiotherapy (PRRT) Received this previous treatment	109 Participants
Type of previous lines Somatostatin analogs (SSA) Not received this previous treatment	57 Participants
Type of previous lines Somatostatin analogs (SSA) Received this previous treatment	342 Participants
Type of previous lines TACE or locoregional therapy Not received this previous treatment	388 Participants
Type of previous lines TACE or locoregional therapy Received this previous treatment	11 Participants
Type of previous lines Targeted kinase inhibitors Not received this previous treatment	291 Participants
Type of previous lines Targeted kinase inhibitors Received this previous treatment	108 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 0
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

Primary

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.