Towards optimal personalized diet and vitamin supplementation in patients with a neuroendocrine tumor; a pilot study
Completed
- Conditions
- 1001471310047635neuroendocrine tumor/distressvitamine
- Registration Number
- NL-OMON41959
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
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
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint is the difference in mean gastro-intestinal symptoms score of<br /><br>the EORTC QLQ-GINET21.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoint will be distress measured by the distress thermometer and<br /><br>change in quality of life as determined by the cancer-specific EORTC QLQ-C30,<br /><br>and the other constructs of the EORTC QLQ-GINET21, empowerment (subscales of<br /><br>the Construct Empowering Outcomes (CEO) questionnaire) at end of study, the<br /><br>difference in nutrition state (Patient-Generated Subjective Global Assessment<br /><br>PG/SGA) and normalization of vitamins and tryptophan levels at end of study<br /><br>measured with quantitative analysis of blood and urine.</p><br>