Trial Outcomes & Findings for Nutrition in Gastroenteropancreatic Neuroendocrine Tumor (NCT NCT04986085)
NCT ID: NCT04986085
Last Updated: 2025-03-28
Results Overview
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.
COMPLETED
399 participants
Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
2025-03-28
Participant Flow
Participant milestones
| Measure |
GEP NET
GEP NET patients in Spain
|
|---|---|
|
Overall Study
STARTED
|
399
|
|
Overall Study
COMPLETED
|
399
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nutrition in Gastroenteropancreatic Neuroendocrine Tumor
Baseline characteristics by cohort
| Measure |
GEP NET
n=399 Participants
GEP NET patients in Spain
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
228 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
380 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or latino
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
399 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group performance status (ECOG-PS)
Score 0
|
213 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group performance status (ECOG-PS)
Score 1
|
125 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group performance status (ECOG-PS)
Score ≥ 2
|
20 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group performance status (ECOG-PS)
Score Unknown
|
41 Participants
n=5 Participants
|
|
Tumor grade; World Health Organization (WHO)
Grade 1
|
147 Participants
n=5 Participants
|
|
Tumor grade; World Health Organization (WHO)
Grade 2
|
197 Participants
n=5 Participants
|
|
Tumor grade; World Health Organization (WHO)
Grade 3
|
50 Participants
n=5 Participants
|
|
Tumor grade; World Health Organization (WHO)
Unknown
|
5 Participants
n=5 Participants
|
|
Tumor Differentiation
Tumors (NET)
|
361 Participants
n=5 Participants
|
|
Tumor Differentiation
Carcinomas (NEC)
|
28 Participants
n=5 Participants
|
|
Tumor Differentiation
Unknown
|
10 Participants
n=5 Participants
|
|
Functionality
Functioning
|
98 Participants
n=5 Participants
|
|
Functionality
Not functioning
|
295 Participants
n=5 Participants
|
|
Functionality
Unknown
|
6 Participants
n=5 Participants
|
|
Primary tumor location
Small intestine
|
177 Participants
n=5 Participants
|
|
Primary tumor location
Pancreas
|
167 Participants
n=5 Participants
|
|
Primary tumor location
Colorectal
|
18 Participants
n=5 Participants
|
|
Primary tumor location
Gastric
|
10 Participants
n=5 Participants
|
|
Primary tumor location
Other / Unknown
|
27 Participants
n=5 Participants
|
|
Metastasis at inclusion
0
|
15 Participants
n=5 Participants
|
|
Metastasis at inclusion
1
|
227 Participants
n=5 Participants
|
|
Metastasis at inclusion
≥ 2
|
157 Participants
n=5 Participants
|
|
Most common sites of metastasis
Liver · Metastasis present
|
332 Participants
n=5 Participants
|
|
Most common sites of metastasis
Liver · No metastasis
|
67 Participants
n=5 Participants
|
|
Most common sites of metastasis
Lymph nodes · Metastasis present
|
86 Participants
n=5 Participants
|
|
Most common sites of metastasis
Lymph nodes · No metastasis
|
313 Participants
n=5 Participants
|
|
Most common sites of metastasis
Peritoneum · Metastasis present
|
55 Participants
n=5 Participants
|
|
Most common sites of metastasis
Peritoneum · No metastasis
|
344 Participants
n=5 Participants
|
|
Most common sites of metastasis
Lung · Metastasis present
|
28 Participants
n=5 Participants
|
|
Most common sites of metastasis
Lung · No metastasis
|
371 Participants
n=5 Participants
|
|
Previous lines of treatment
1
|
217 Participants
n=5 Participants
|
|
Previous lines of treatment
2
|
92 Participants
n=5 Participants
|
|
Previous lines of treatment
≥ 2
|
90 Participants
n=5 Participants
|
|
Type of previous lines
Somatostatin analogs (SSA) · Received this previous treatment
|
342 Participants
n=5 Participants
|
|
Type of previous lines
Somatostatin analogs (SSA) · Not received this previous treatment
|
57 Participants
n=5 Participants
|
|
Type of previous lines
Peptide receptor radiotherapy (PRRT) · Received this previous treatment
|
109 Participants
n=5 Participants
|
|
Type of previous lines
Peptide receptor radiotherapy (PRRT) · Not received this previous treatment
|
290 Participants
n=5 Participants
|
|
Type of previous lines
Targeted kinase inhibitors · Received this previous treatment
|
108 Participants
n=5 Participants
|
|
Type of previous lines
Targeted kinase inhibitors · Not received this previous treatment
|
291 Participants
n=5 Participants
|
|
Type of previous lines
Chemotherapy · Received this previous treatment
|
80 Participants
n=5 Participants
|
|
Type of previous lines
Chemotherapy · Not received this previous treatment
|
319 Participants
n=5 Participants
|
|
Type of previous lines
Clinical trial · Received this previous treatment
|
42 Participants
n=5 Participants
|
|
Type of previous lines
Clinical trial · Not received this previous treatment
|
357 Participants
n=5 Participants
|
|
Type of previous lines
TACE or locoregional therapy · Received this previous treatment
|
11 Participants
n=5 Participants
|
|
Type of previous lines
TACE or locoregional therapy · Not received this previous treatment
|
388 Participants
n=5 Participants
|
|
Type of previous lines
Immunotherapy · Received this previous treatment
|
7 Participants
n=5 Participants
|
|
Type of previous lines
Immunotherapy · Not received this previous treatment
|
392 Participants
n=5 Participants
|
|
Type of previous lines
Others · Received this previous treatment
|
6 Participants
n=5 Participants
|
|
Type of previous lines
Others · Not received this previous treatment
|
393 Participants
n=5 Participants
|
PRIMARY outcome
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)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.
Outcome measures
| Measure |
GEP NET
n=399 Participants
GEP NET patients in Spain
|
|---|---|
|
Prevalence of Malnutrition in GEP NET
No malnutrition
|
152 Participants
|
|
Prevalence of Malnutrition in GEP NET
Malnutrition (GLIM criteria)
|
247 Participants
|
PRIMARY outcome
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)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.
Outcome measures
| Measure |
GEP NET
n=399 Participants
GEP NET patients in Spain
|
|---|---|
|
Risk of Malnutrition in GEP NET
Low risk
|
264 Participants
|
|
Risk of Malnutrition in GEP NET
Intermediate risk
|
67 Participants
|
|
Risk of Malnutrition in GEP NET
High risk
|
56 Participants
|
|
Risk of Malnutrition in GEP NET
Missing
|
12 Participants
|
SECONDARY outcome
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)Population: The endpoint is reported in overall population and in subgroups. according to their sex and malnutrition status. The analyzed patient number in each subgroup might be inferior to the full sample size as some patients may have missing BMI , or unknown GLIM malnutrition status.
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
Outcome measures
| Measure |
GEP NET
n=399 Participants
GEP NET patients in Spain
|
|---|---|
|
Body Mass Index
Male · Underweight (BMI < 18.5)
|
6 Participants
|
|
Body Mass Index
Female · Normal (BMI 18.5 - 25)
|
89 Participants
|
|
Body Mass Index
Male · Normal (BMI 18.5 - 25)
|
96 Participants
|
|
Body Mass Index
Male · Overweight (BMI 25 - 30)
|
95 Participants
|
|
Body Mass Index
Male · Obese (BMI >= 30)
|
31 Participants
|
|
Body Mass Index
Female · Underweight (BMI < 18.5)
|
17 Participants
|
|
Body Mass Index
Female · Overweight (BMI 25 - 30)
|
53 Participants
|
|
Body Mass Index
Female · Obese (BMI >= 30)
|
12 Participants
|
|
Body Mass Index
Malnutrition (GLIM) · Underweight (BMI < 18.5)
|
23 Participants
|
|
Body Mass Index
Malnutrition (GLIM) · Normal (BMI 18.5 - 25)
|
116 Participants
|
|
Body Mass Index
Malnutrition (GLIM) · Overweight (BMI 25 - 30)
|
80 Participants
|
|
Body Mass Index
Malnutrition (GLIM) · Obese (BMI >= 30)
|
28 Participants
|
|
Body Mass Index
No malnutrition (GLIM) · Underweight (BMI < 18.5)
|
0 Participants
|
|
Body Mass Index
No malnutrition (GLIM) · Normal (BMI 18.5 - 25)
|
68 Participants
|
|
Body Mass Index
No malnutrition (GLIM) · Overweight (BMI 25 - 30)
|
68 Participants
|
|
Body Mass Index
No malnutrition (GLIM) · Obese (BMI >= 30)
|
15 Participants
|
|
Body Mass Index
Overall · Underweight (BMI < 18.5)
|
23 Participants
|
|
Body Mass Index
Overall · Normal (BMI 18.5 - 25)
|
185 Participants
|
|
Body Mass Index
Overall · Overweight (BMI 25 - 30)
|
148 Participants
|
|
Body Mass Index
Overall · Obese (BMI >= 30)
|
43 Participants
|
SECONDARY outcome
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)Population: The endpoint is reported in overall population and in subgroups. according to their sex and malnutrition status. The analyzed patient number in each subgroup might be inferior to the full sample size as some patients may have missing BMI , or unknown GLIM malnutrition status.
Body fat mass calculated by bioimpedance
Outcome measures
| Measure |
GEP NET
n=399 Participants
GEP NET patients in Spain
|
|---|---|
|
Body Fat
Male
|
58.2 Kg
Interval 18.4 to 84.5
|
|
Body Fat
Female
|
41.5 Kg
Interval 8.7 to 73.5
|
|
Body Fat
Malnutrition (GLIM)
|
47.0 Kg
Interval 8.7 to 77.4
|
|
Body Fat
No Malnutrition (GLIM)
|
57.3 Kg
Interval 36.7 to 84.5
|
|
Body Fat
Overall
|
51.4 Kg
Interval 8.7 to 84.5
|
SECONDARY outcome
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)Population: The endpoint is reported in overall population and in subgroups. according to their sex and malnutrition status. The analyzed patient number in each subgroup might be inferior to the full sample size as some patients may have missing BMI , or unknown GLIM malnutrition status.
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.
Outcome measures
| Measure |
GEP NET
n=399 Participants
GEP NET patients in Spain
|
|---|---|
|
Phase Angle
Male
|
5.5 degrees
Interval 1.8 to 9.0
|
|
Phase Angle
Female
|
4.8 degrees
Interval 3.0 to 11.0
|
|
Phase Angle
Malnutrition (GLIM)
|
5.0 degrees
Interval 2.2 to 11.0
|
|
Phase Angle
No malnutrition (GLIM)
|
5.6 degrees
Interval 1.8 to 9.0
|
|
Phase Angle
Overall
|
5.1 degrees
Interval 1.8 to 11.0
|
SECONDARY outcome
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)Population: The endpoint is reported in overall population and in subgroups. according to the malnutrition status. The analyzed patient number in each subgroup might be inferior to the full sample size as some patients may have missing BMI , or unknown GLIM malnutrition status.
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).
Outcome measures
| Measure |
GEP NET
n=399 Participants
GEP NET patients in Spain
|
|---|---|
|
Nutritional Risk Screening (NRS) Rates
Malnutrition (GLIM)
|
1.5 Score
Interval 0.0 to 5.0
|
|
Nutritional Risk Screening (NRS) Rates
No malnutrition (GLIM)
|
0 Score
Interval 0.0 to 4.0
|
|
Nutritional Risk Screening (NRS) Rates
Overall
|
1 Score
Interval 0.0 to 2.0
|
SECONDARY outcome
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)Population: The endpoint is reported in overall population and in subgroups. according to the malnutrition status
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)
Outcome measures
| Measure |
GEP NET
n=399 Participants
GEP NET patients in Spain
|
|---|---|
|
Subjective Global Assessment (SGA) Rates
No malnutrition (GLIM) · Missing data
|
0 Participants
|
|
Subjective Global Assessment (SGA) Rates
Malnutrition (GLIM) · Good nutritional status
|
144 Participants
|
|
Subjective Global Assessment (SGA) Rates
Malnutrition (GLIM) · Moderate malnutrition or risk of malnutrition
|
79 Participants
|
|
Subjective Global Assessment (SGA) Rates
Malnutrition (GLIM) · Severe malnutrition
|
22 Participants
|
|
Subjective Global Assessment (SGA) Rates
Malnutrition (GLIM) · Missing data
|
0 Participants
|
|
Subjective Global Assessment (SGA) Rates
No malnutrition (GLIM) · Good nutritional status
|
140 Participants
|
|
Subjective Global Assessment (SGA) Rates
No malnutrition (GLIM) · Moderate malnutrition or risk of malnutrition
|
8 Participants
|
|
Subjective Global Assessment (SGA) Rates
No malnutrition (GLIM) · Severe malnutrition
|
1 Participants
|
|
Subjective Global Assessment (SGA) Rates
Overall · Good nutritional status
|
285 Participants
|
|
Subjective Global Assessment (SGA) Rates
Overall · Moderate malnutrition or risk of malnutrition
|
87 Participants
|
|
Subjective Global Assessment (SGA) Rates
Overall · Severe malnutrition
|
23 Participants
|
|
Subjective Global Assessment (SGA) Rates
Overall · Missing data
|
4 Participants
|
Adverse Events
GEP NET
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
A responsible Person Designated by the Sponsor
Grupo Español de Tumores Neuroendocrinos y Endocrinos
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place