Towards optimal personalized diet and vitamin supplementation in patients with a neuroendocrine tumor.

Completed

Conditions: neuroendocrine tumor
vitamin
10047635
10014713

Registration Number: NL-OMON43061

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 53

Inclusion Criteria

* Adult patients aged * 18 years
* NET-patients with serotonine producing or non-serotonin producing tumors, with gastro-intestinal, pancreatic, bronchopulmonary or unknown primary tumor site and with metastasized or irresectable disease.
* Ability to comprehend Dutch (both reading and writing).
* Written informed consent provided.
* Use of somatostatin analogue for > 6 months.

Exclusion Criteria

* Estimated life expectancy less than 6 months.
* Patients who have a history of another primary malignancy, except for radical and adequately treated malignancies from which the patient has been disease free for * 1 year.
* Major abdominal surgery during study period.
* Patients already participated in the DIVIT-pilot study
* Known hypersensitivity of (components of) somatostatin analogue

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the change in the proportion of patients with normal<br /><br>vitamin values measured with quantitative analysis of blood and urine.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint will be the nutrition state (Patient-Generated Subjective<br /><br>Global Assessment PG/SGA), distress measured by the distress thermometer and<br /><br>change in quality of life as determined by the NET-specific EORTC QLQ-GINET21<br /><br>and the cancer-specific EORTC QLQ-C30, and the difference of self-reported<br /><br>healthy eating pattern.<br /><br>Furthermore a semi qualitative interview will be performed at t=18 to<br /><br>investigate the satisfaction of patients about the intervention. </p><br>