DIVIT Study Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor

Study Overview
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Brief Summary
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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
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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.

Official Title
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Towards Optimal Personalized Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor

Conditions
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Neuroendocrine Tumor

Intervention / Treatment
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* Dietary Supplement: Vitamin supplement;
* Other: Diet advice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin supplement and diet advice<br>Single arm. Patient be prescribed vitamin supplement if vitamin deficiencies are diagnosed and will get diet advice | Dietary Supplement: Vitamin supplement;<br>* Vitamin K, vitamin A, vitamin D, vitamin E, nicotinamide, vitamin B12<br>Other: Diet advice<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in the proportion of patients with normal vitamin values | the change in the proportion of patients with normal vitamin values measured with quantitative analysis of blood and urine | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutrition state | As measured with the total score with Patient-Generated Subjective Global Assessment (PG/SGA). | 18 weeks | 
| distress | measured by the distress thermometer and problem list | 18 weeks | 
| problems | as measured with the problem list.(the mean of each item) | 18 weeks | 
| change in quality of life | determined by the QLQ-GINET21 (a NET-specific EORTC quality of life questionnaire) and the cancer-specific EORTC QLQ-C30, | 18 weeks | 
| difference in the self-reported healthy eating pattern. | as measured with a self-constructed scale | 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuroendocrine tumor, vitamin, diet