Ignite Creation Date:
2024-05-06 @ 7:11 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02481804
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2015-01-06
Brief Title:
Optimal Feeding for NET Patients
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Towards Optimal Personalized Diet and Vitamin Supplementation in NET Patients a Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIVIT-pilot
Brief 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 andor 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 PGSGA 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
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 PGSGA 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None