Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03143946
Other study ID # 201600626
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2016
Est. completion date August 2019

Study information

Verified date May 2024
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date August 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients aged = 18 years - NET-patients with serotonin producing or non-serotonin producing tumors, with gastro-intestinal, pancreatic, bronchopulmonary or unknown primary tumor site and with metastasized or irresectable disease - Ability to comprehend Dutch (both reading and writing). - Written informed consent provided. - Use of somatostatin analogue for > 6 months. Exclusion Criteria: - Estimated life expectancy less than 6 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 = 1 year. - Major abdominal surgery during study period. - Patients already participated in the DIVIT-pilot study - Known hypersensitivity of (components of) somatostatin analogue

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Vitamin supplement;
Vitamin K, vitamin A, vitamin D, vitamin E, nicotinamide, vitamin B12
Other:
Diet advice


Locations

Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary the change in the proportion of patients with normal vitamin values the change in the proportion of patients with normal vitamin values measured with quantitative analysis of blood and urine 18 weeks
Secondary nutrition state As measured with the total score with Patient-Generated Subjective Global Assessment (PG/SGA). 18 weeks
Secondary distress measured by the distress thermometer and problem list 18 weeks
Secondary problems as measured with the problem list.(the mean of each item) 18 weeks
Secondary change in quality of life determined by the QLQ-GINET21 (a NET-specific EORTC quality of life questionnaire) and the cancer-specific EORTC QLQ-C30, 18 weeks
Secondary difference in the self-reported healthy eating pattern. as measured with a self-constructed scale 18 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04837885 - Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases Phase 2
Completed NCT00789841 - Gastrointestinal Motility in Patients With Neuroendocrine Tumors N/A
Recruiting NCT05069220 - 18F-MFBG PET/CT in the Evaluation of Neural Crest Tumor Early Phase 1
Completed NCT05816720 - Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)
Active, not recruiting NCT04400474 - Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study Phase 2
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes N/A
Completed NCT01849523 - Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor: a Randomized Pilot Study N/A
Recruiting NCT01448083 - Heart/Mediastinal Ratio Study for Potential Equivalence of Heart/Mediastinal Ratios at One and Two Hours to the Traditional Heart/Mediastinal Ratio Obtained at Four Hours N/A
Completed NCT00804336 - Pasireotide in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors Phase 1
Active, not recruiting NCT02092714 - Molecular Analysis in Tissue Samples From Patients With Advanced or Metastatic Neuroendocrine Tumors
Terminated NCT04073017 - Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency N/A
Completed NCT00434109 - Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization Phase 2
Completed NCT02472678 - Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor N/A
Completed NCT02481804 - Optimal Feeding for NET Patients N/A
Completed NCT02147106 - Use of Video Consultation in Follow-up Care for Patients With a Neuroendocrine Tumor: a Feasibility Study
Completed NCT00165230 - Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors Phase 2
Active, not recruiting NCT03012789 - Surgical Intervention and the NETest N/A
Not yet recruiting NCT02038738 - 68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors Phase 1/Phase 2
Completed NCT01024387 - AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors Phase 2
Terminated NCT00227617 - Combination Chemotherapy and Bevacizumab in Treating Patients With Advanced Neuroendocrine Tumors Phase 2/Phase 3