Clinical trial NCT03143946: DIVIT Study Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor
Official title: Towards Optimal Personalized Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuroendocrine Tumor
Keywords: neuroendocrine tumor
vitamin
diet
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the change in the proportion of patients with normal vitamin values
timeFrame: 18 weeks
Secondary outcomes:
measure: nutrition state
timeFrame: 18 weeks
measure: distress
timeFrame: 18 weeks
measure: problems
timeFrame: 18 weeks
measure: change in quality of life
timeFrame: 18 weeks
measure: difference in the self-reported healthy eating pattern.
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Annemiek ME Walenkamp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: