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

Primary Purpose

Neuroendocrine Tumor

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Vitamin supplement;
Diet advice
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumor focused on measuring neuroendocrine tumor, vitamin, diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin supplement and diet advice

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

nutrition state
As measured with the total score with Patient-Generated Subjective Global Assessment (PG/SGA).
distress
measured by the distress thermometer and problem list
problems
as measured with the problem list.(the mean of each item)
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,
difference in the self-reported healthy eating pattern.
as measured with a self-constructed scale

Full Information

First Posted
October 11, 2016
Last Updated
October 1, 2019
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT03143946
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumor
Keywords
neuroendocrine tumor, vitamin, diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin supplement and diet advice
Arm Type
Experimental
Arm Description
Single arm. Patient be prescribed vitamin supplement if vitamin deficiencies are diagnosed and will get diet advice
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin supplement;
Intervention Description
Vitamin K, vitamin A, vitamin D, vitamin E, nicotinamide, vitamin B12
Intervention Type
Other
Intervention Name(s)
Diet advice
Primary Outcome Measure Information:
Title
the change in the proportion of patients with normal vitamin values
Description
the change in the proportion of patients with normal vitamin values measured with quantitative analysis of blood and urine
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
nutrition state
Description
As measured with the total score with Patient-Generated Subjective Global Assessment (PG/SGA).
Time Frame
18 weeks
Title
distress
Description
measured by the distress thermometer and problem list
Time Frame
18 weeks
Title
problems
Description
as measured with the problem list.(the mean of each item)
Time Frame
18 weeks
Title
change in quality of life
Description
determined by the QLQ-GINET21 (a NET-specific EORTC quality of life questionnaire) and the cancer-specific EORTC QLQ-C30,
Time Frame
18 weeks
Title
difference in the self-reported healthy eating pattern.
Description
as measured with a self-constructed scale
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemiek ME Walenkamp, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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

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