Neuroendocrine Tumor Clinical Trial
Official title:
Towards Optimal Personalized Diet and Vitamin Supplementation in NET Patients; a Pilot Study
This study aims to investigate if optimal personalized consultation by a dietician for a healthy diet focused on food which contains sufficient vitamins and minerals improves gastrointestinal symptoms as determined by an improved score in the gastrointestinal symptoms of the NET specific EORTC QLQ-GINET21 at end of study.
Rationale: Patients with neuroendocrine tumors (NET) have a rare, slowly progressing
disease. Therefore they undergo many treatments such as surgery followed by long-lasting
systemic treatments with somatostatin analogues. These procedures can each result in
increased diarrhea and loss of critical food components in the stools such as fat. This can
lead amongst others, to major loss of fat-soluble vitamins. Those patients who in addition
have an ongoing serotonin production may experience shortage in the circulating essential
amino acid tryptophan. Serotonin is derived from the essential amino acid tryptophan.
Tryptophan is a precursor of niacin (vitamin B3) which is critical for normal cellular
metabolism. In case of high serotonin production in neuroendocrine tumor patients tryptophan
and/or niacin can be deficient leading to symptoms including pellagra. Suppletion of
tryptophan might facilitate serotonin production and therefore, is undesirable in patients
with serotonin producing neuroendocrine tumors.
Strikingly little is known about how NET patients should be best supported for the deficits
they develop during their long-lasting disease. Also the precise effect of diet advices for
diarrhea and fat-soluble vitamins and vitamin B3, in this patient group is unknown.
Patients with NET are faced with a serious chronic disease. This makes this patients group
extremely motivated to be involved in their treatment and to "self-manage" their disease as
much as possible.
Objective: This study aims to investigate if optimal personalized consultation by a
dietician for a healthy diet focused on food which contains sufficient vitamins and minerals
improves gastrointestinal symptoms as determined by an improved score in the
gastrointestinal symptoms of the NET specific EORTC QLQ-GINET21 at end of study. Secondary
aims are decrease in distress on the distress thermometer, improvement 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 questionnaire) at
end of study, an improvement 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.
Study design: This is a single center 18 week open-label, non-comparative, single-arm,
experimental pilot study. In this pilot we want to examine the effect sizes of the
gastrointestinal symptoms of the NET specific EORTC QLQ-GINET21 of the patients after the
dietary intervention. Four weeks after inclusion adult patients with metastasized NET and
chronic use (>6 months) of a somatostatin analogue will start with the dietary intervention.
Effects of the intervention will be evaluated by questionnaires and vitamin values in blood
and urine.
Patients fill out these questionnaires at baseline, after four weeks, and after 18 weeks.
Furthermore at baseline, after four weeks, and after 18 weeks vitamin values in blood and
urine will be measured and at baseline.
Study population: Patients that are treated in the University Medical Center Groningen for
metastasized NET treated with a somatostatin analogue for more than 6 months will be
eligible.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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