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

NCT ID: NCT03143946

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-15
• Study Completion Date: 2019-08-31

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.

Conditions

Neuroendocrine Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin supplement and diet advice

Single arm. Patient be prescribed vitamin supplement if vitamin deficiencies are diagnosed and will get diet advice

Group Type: EXPERIMENTAL

Vitamin supplement;

Intervention Type: DIETARY_SUPPLEMENT

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

Diet advice

Intervention Type: OTHER

Interventions

Vitamin supplement;

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

Intervention Type: DIETARY_SUPPLEMENT

Diet advice

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annemiek ME Walenkamp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

201600626

Identifier Type: -

Identifier Source: org_study_id