Towards optimal personalized diet and vitamin supplementation in patients with a neuroendocrine tumor.

Towards optimal personalized diet and vitamin supplementation in patients with a neuroendocrine tumor. - DIVIT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43061

Enrollment

Registered

2016-12-05

Start date

2016-12-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuroendocrine tumor vitamin

Interventions

In the first four weeks after inclusion patients will get standard care. The measurements, including

baseline characteristics, quantitative analysis of blood and urine and questionnaires will be performed at baseline (t=0), after four weeks (t=4), and after 18 weeks (t=18). Furthermore, at t=18 a s

diet

neuroendocrine tumor

vitamin

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Adult patients aged * 18 years * NET-patients with serotonine 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

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

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the change in the proportion of patients with normal vitamin values measured with quantitative analysis of blood and urine.	—

Secondary

Measure	Time frame
Secondary endpoint will be the nutrition state (Patient-Generated Subjective Global Assessment PG/SGA), distress measured by the distress thermometer and change in quality of life as determined by the NET-specific EORTC QLQ-GINET21 and the cancer-specific EORTC QLQ-C30, and the difference of self-reported healthy eating pattern. Furthermore a semi qualitative interview will be performed at t=18 to investigate the satisfaction of patients about the intervention.	—

Measure

Time frame

Secondary endpoint will be the nutrition state (Patient-Generated Subjective Global Assessment PG/SGA), distress measured by the distress thermometer and change in quality of life as determined by the NET-specific EORTC QLQ-GINET21 and the cancer-specific EORTC QLQ-C30, and the difference of self-reported healthy eating pattern. Furthermore a semi qualitative interview will be performed at t=18 to investigate the satisfaction of patients about the intervention.

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)