Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Micronutrients

All Drugs and Chemicals

Vasodilator Agents

Lipid Regulating Agents

Bone Density Conservation Agents

Coagulants

Hematinics

Antineoplastic Agents

Vitamins

Niacinamide

Niacin

Nicotinic Acids

Vitamin D

Cholecalciferol

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Vitamin B Complex

Vitamin K

Vitamin B 12

Hydroxocobalamin

Vitamin A

Retinol palmitate

Trace Elements

Nicotinamide

Nicotinic Acid

Vitamin B3

Vitamin D3

Calciferol

Tocopherol

Tocotrienol

Methylcobalamin

Menadione

Menaquinone

Naphthoquinone

Phylloquinone

Vitamin B12

Cobalamin

Cyanocobalamin

Retinol

Single arm. Patient be prescribed vitamin supplement if vitamin deficiencies are diagnosed and will get diet advice

Vitamin K, vitamin A, vitamin D, vitamin E, nicotinamide, vitamin B12

Vitamin supplement;

Diet advice

Annemiek ME Walenkamp, MD, PhD

This study aims to investigate if the proportion of neuroendocrine tumor (NET) patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet, Effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. The measurements, will be performed at baseline (t=0), after 4 weeks (t=4) and after 18 weeks at end of study (t=18). Furthermore at t=18 a semi-qualitative interview will be performed.

Objective:

This study aims to investigate if the proportion of NET patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet.

Methods:

This is a single center 18-week open-label, non-comparative, single-arm, intervention study. After inclusion and the first measurements, adult patients with metastasized or irresectable NET will continue with four weeks of standard treatment. After these four weeks participants with vitamin values below normal will get vitamin suppletion for each deficient vitamin and all participants will get the dietary intervention during 14 weeks. Effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. The measurements, including; baseline characteristics, quantitative analysis of blood and urine and questionnaires will be performed at baseline (t=0), after 4 weeks (t=4) and after 18 weeks at end of study (t=18). Furthermore at t=18 a semi-qualitative interview will be performed.

DIVIT Study Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor

Towards Optimal Personalized Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor

the change in the proportion of patients with normal vitamin values measured with quantitative analysis of blood and urine

As measured with the total score with Patient-Generated Subjective Global Assessment (PG/SGA).

measured by the distress thermometer and problem list

as measured with the problem list.(the mean of each item)

determined by the QLQ-GINET21 (a NET-specific EORTC quality of life questionnaire) and the cancer-specific EORTC QLQ-C30,

as measured with a self-constructed scale

University Medical Center Groningen

Psychotropic Drugs

Amino Acids

Tryptophan

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.

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.

Dietary intervention

Standard treatment

A. M.E. Walenkamp, MD, PhD

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.

Optimal Feeding for NET Patients

Towards Optimal Personalized Diet and Vitamin Supplementation in NET Patients; a Pilot Study

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

change in distress, as measuerd by the distress thermometer,

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 the difference in nutrition state (Patient-Generated Subjective Global Assessment PG/SGA)

normalization of vitamins and tryptophan levels at end of study measured with quantitative analysis of blood and urine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DIVIT Study Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor	NCT03143946	Neuroendocrine ...	Vitamin supplem... Diet advice	18 Years -	University Medical Center Groningen
Optimal Feeding for NET Patients	NCT02481804	Neuroendocrine ...	Dietary interve... Standard treatm...	18 Years - 90 Years	University Medical Center Groningen
DIVIT Study Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor	NCT03143946	Neuroendocrine ...	Vitamin supplem... Diet advice	18 Years -	University Medical Center Groningen
Optimal Feeding for NET Patients	NCT02481804	Neuroendocrine ...	Dietary interve... Standard treatm...	18 Years - 90 Years	University Medical Center Groningen
DIVIT Study Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor	NCT03143946	Neuroendocrine ...	Vitamin supplem... Diet advice	18 Years -	University Medical Center Groningen

Spots Global Cancer Trial Database for vitamin

Every month we try and update this database with for vitamin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vitamin

Every month we try and update this database with for vitamin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vitamin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.