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

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

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.

Study Overview

• Status: Completed
• Conditions: Neuroendocrine Tumor
• Intervention / Treatment: Dietary supplement: Vitamin supplement;; Other: Diet advice

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: diet; neuroendocrine tumor; vitamin
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: 201600626

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No