Neuroendocrine Tumor
Conditions
Keywords
neuroendocrine tumor, vitamin, diet
Brief summary
This study aims to investigate if the proportion of neuroendocrine tumor (NET) patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet, Effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. The measurements, will be performed at baseline (t=0), after 4 weeks (t=4) and after 18 weeks at end of study (t=18). Furthermore at t=18 a semi-qualitative interview will be performed.
Detailed description
Objective: This study aims to investigate if the proportion of NET patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet. Methods: This is a single center 18-week open-label, non-comparative, single-arm, intervention study. After inclusion and the first measurements, adult patients with metastasized or irresectable NET will continue with four weeks of standard treatment. After these four weeks participants with vitamin values below normal will get vitamin suppletion for each deficient vitamin and all participants will get the dietary intervention during 14 weeks. Effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. The measurements, including; baseline characteristics, quantitative analysis of blood and urine and questionnaires will be performed at baseline (t=0), after 4 weeks (t=4) and after 18 weeks at end of study (t=18). Furthermore at t=18 a semi-qualitative interview will be performed.
Interventions
DIETARY_SUPPLEMENTVitamin supplement;
Vitamin K, vitamin A, vitamin D, vitamin E, nicotinamide, vitamin B12
OTHERDiet advice
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients aged ≥ 18 years * NET-patients with serotonin 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change in the proportion of patients with normal vitamin values | 18 weeks | the change in the proportion of patients with normal vitamin values measured with quantitative analysis of blood and urine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| nutrition state | 18 weeks | As measured with the total score with Patient-Generated Subjective Global Assessment (PG/SGA). |
| distress | 18 weeks | measured by the distress thermometer and problem list |
| problems | 18 weeks | as measured with the problem list.(the mean of each item) |
| change in quality of life | 18 weeks | determined by the QLQ-GINET21 (a NET-specific EORTC quality of life questionnaire) and the cancer-specific EORTC QLQ-C30, |
| difference in the self-reported healthy eating pattern. | 18 weeks | as measured with a self-constructed scale |
Countries
Netherlands
Outcome results
None listed