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

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Vitamin supplement and diet advice	Diet advice	Single arm. Patient be prescribed vitamin supplement if vitamin deficiencies are diagnosed and will get diet advice
Vitamin supplement and diet advice	Vitamin supplement;	Single arm. Patient be prescribed vitamin supplement if vitamin deficiencies are diagnosed and will get diet advice

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
difference in the self-reported healthy eating pattern.	18 weeks	as measured with a self-constructed scale
nutrition state	18 weeks	As measured with the total score with Patient-Generated Subjective Global Assessment (PG/SGA).
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,
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)

Locations (1): University Medical Center Groningen
🇳🇱
Groningen, Netherlands

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