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

Neuroendocrine Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143946
• Other study ID #: 201600626
• Status: Completed
• Phase: N/A
• Start date: December 15, 2016
• Est. completion date: August 2019

Study information

• Verified date: October 2019
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumor
• Neuroendocrine Tumors

Intervention

Dietary Supplement:
• Vitamin supplement;
Vitamin K, vitamin A, vitamin D, vitamin E, nicotinamide, vitamin B12

Other:
• Diet advice

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	nutrition state	As measured with the total score with Patient-Generated Subjective Global Assessment (PG/SGA).	18 weeks
Secondary	distress	measured by the distress thermometer and problem list	18 weeks
Secondary	problems	as measured with the problem list.(the mean of each item)	18 weeks
Secondary	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
Secondary	difference in the self-reported healthy eating pattern.	as measured with a self-constructed scale	18 weeks