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Towards optimal personalized diet and vitamin supplementation in patients with a neuroendocrine tumor; a pilot study

Towards optimal personalized diet and vitamin supplementation in patients with a neuroendocrine tumor; a pilot study - DIVIT-pilot

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41959
Enrollment
15
Registered
2015-05-06
Start date
2015-05-01
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/distress vitamine

Interventions

In the first four weeks after inclusion patients will get standard care. Patients fill out the questionnaires at baseline, after four weeks, and after 18 weeks. The first month will be used to obser
diet
neuroendocrine tumor
tryptophane

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Adult NET patients (aged >= 18 years of age), with serotonine producing or non-serotonin producing tumors, with any tumor site and disease stage. • Use of somatostatin analogue for > 6 months. • Ability to comprehend Dutch (both reading and writing). • Written informed consent provided.

Exclusion criteria

Exclusion criteria: • Estimated life expectancy less than 3 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 >= 3 years. • • Major abdominal surgery during study period. • Known hypersensitivity of (components of) somatostatin analogue.

Design outcomes

Primary

MeasureTime frame
Primary endpoint is the difference in mean gastro-intestinal symptoms score of the EORTC QLQ-GINET21.

Secondary

MeasureTime frame
Secondary endpoint will be distress measured by the distress thermometer and change in quality of life as determined by the cancer-specific EORTC QLQ-C30, and the other constructs of the EORTC QLQ-GINET21, empowerment (subscales of the Construct Empowering Outcomes (CEO) questionnaire) at end of study, the difference in nutrition state (Patient-Generated Subjective Global Assessment PG/SGA) and normalization of vitamins and tryptophan levels at end of study measured with quantitative analysis of blood and urine.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)