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

University Medical Center Groningen53 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuroendocrine Tumor

Interventions

Vitamin supplement;DIETARY_SUPPLEMENT

Vitamin K, vitamin A, vitamin D, vitamin E, nicotinamide, vitamin B12

Diet adviceOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Groningen

Groningen, Netherlands

Outcomes

Primary Outcomes

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

Time frame: 18 weeks

Secondary Outcomes

nutrition state

As measured with the total score with Patient-Generated Subjective Global Assessment (PG/SGA).

Time frame: 18 weeks

distress

measured by the distress thermometer and problem list

Time frame: 18 weeks

problems

as measured with the problem list.(the mean of each item)

Time frame: 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,

Time frame: 18 weeks

difference in the self-reported healthy eating pattern.

as measured with a self-constructed scale

Time frame: 18 weeks

Data from ClinicalTrials.gov

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