Optimal Feeding for NET Patients (DIVIT-pilot)

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.

Study Overview

• Status: Completed
• Conditions: Neuroendocrine Tumor
• Intervention / Treatment: Other: Dietary intervention; Other: Standard treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 RB
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dietary intervention; There is one arm. Patients will first have an observation period, whre hey will get standard treatment during four weeks. Thereafter they will have the dietary intervention during 14 weeks.

Other: Dietary intervention; 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.; Other: Standard treatment; Standard treatment will be continued

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gastro-intestinal symptoms	Primary endpoint is the difference in mean gastro-intestinal symptoms score of the EORTC QLQ-GINET21	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
distress	change in distress, as measuerd by the distress thermometer,	18 weeks
quality of life	quality of life as determined by the cancer-specific EORTC QLQ-C30, and the other constructs of the EORTC QLQ-GINET21	18 weeks
empowerment at end of study	empowerment (subscales of the Construct Empowering Outcomes (CEO) questionnaire) at end of study	18 weeks
nutrition state	the difference in the difference in nutrition state (Patient-Generated Subjective Global Assessment PG/SGA)	18 weeks
vitamins and tryptophan levels	normalization of vitamins and tryptophan levels at end of study measured with quantitative analysis of blood and urine	18 weeks

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: A. M.E. Walenkamp, MD, PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 6, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimated): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: diet; vitamin
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors
• Other Study ID Numbers: 05012015