neuroendocrine tumor/distress vitamine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Adult NET patients (aged >= 18 years of age), with serotonine producing or non-serotonin producing tumors, with any tumor site and disease stage. • Use of somatostatin analogue for > 6 months. • Ability to comprehend Dutch (both reading and writing). • Written informed consent provided.
Exclusion criteria
Exclusion criteria: • Estimated life expectancy less than 3 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 >= 3 years. • • Major abdominal surgery during study period. • Known hypersensitivity of (components of) somatostatin analogue.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the difference in mean gastro-intestinal symptoms score of the EORTC QLQ-GINET21. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint will be distress measured by the distress thermometer and change in quality of life as determined by the cancer-specific EORTC QLQ-C30, and the other constructs of the EORTC QLQ-GINET21, empowerment (subscales of the Construct Empowering Outcomes (CEO) questionnaire) at end of study, the difference in nutrition state (Patient-Generated Subjective Global Assessment PG/SGA) and normalization of vitamins and tryptophan levels at end of study measured with quantitative analysis of blood and urine. | — |
Countries
The Netherlands