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

Sponsor

University Medical Center Groningen (Other)

Overall Status

Completed

CT.gov ID

NCT03143946

Collaborator

(none)

Enrollment

Location

Arm

31.5

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroendocrine Tumor	Dietary Supplement: Vitamin supplement; Other: Diet advice	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 15, 2016

Actual Primary Completion Date :

Aug 1, 2019

Actual Study Completion Date :

Aug 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Groningen	Groningen		Netherlands	9713 GZ

Sponsors and Collaborators

University Medical Center Groningen

Investigators

Principal Investigator: Annemiek ME Walenkamp, MD, PhD, University Medical Center Groningen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

A.M.E. Walenkamp, Principal investigator, University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT03143946

Other Study ID Numbers:

201600626

First Posted:

May 8, 2017

Last Update Posted:

Oct 2, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by A.M.E. Walenkamp, Principal investigator, University Medical Center Groningen

neuroendocrine tumor

vitamin

diet

Additional relevant MeSH terms:

Neuroendocrine Tumors

Vitamins

Study Results

No Results Posted as of Oct 2, 2019