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

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: Neuroendocrine Tumor

Treatments: Dietary Supplement: Vitamin supplement;; Other: Diet advice

Study type: Interventional

Funder types: Other

Identifiers

NCT03143946

201600626

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Vitamin supplement and diet advice

Experimental group

Description:

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

Treatment:

Other: Diet advice

Dietary Supplement: Vitamin supplement;