Optimal Feeding for NET Patients
Condition: Neuroendocrine Tumor
MeSH terms: Neuroendocrine Tumors
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Dietary intervention; Standard treatment
Intervention type(s): Other; Other
Intervention description(s): Patients will be counseled by a dietician for 14 weeks. A tailored diet advice for each NET patient will be based on the individual situation which includes gastrointestinal complaints, the location of the tumor, additional treatments like previous surgery and measured vitamine and tryptophan levels.
Dietician consults will be conducted by 1 out-patient visit and 3 follow up contacts.; Standard treatment will be continued
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diet; vitamin