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

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ClinicalTrials.gov Identifier: NCT03143946
Recruitment Status : Active, not recruiting
First Posted : May 8, 2017
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
A.M.E. Walenkamp, University Medical Center Groningen

Brief 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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumor Dietary Supplement: Vitamin supplement; Other: Diet advice Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Towards Optimal Personalized Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor
Actual Study Start Date : December 15, 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019


Arm Intervention/treatment
Experimental: Vitamin supplement and diet advice
Single arm. Patient be prescribed vitamin supplement if vitamin deficiencies are diagnosed and will get diet advice
Dietary Supplement: Vitamin supplement;
Vitamin K, vitamin A, vitamin D, vitamin E, nicotinamide, vitamin B12

Other: Diet advice



Primary Outcome Measures :
  1. the change in the proportion of patients with normal vitamin values [ Time Frame: 18 weeks ]
    the change in the proportion of patients with normal vitamin values measured with quantitative analysis of blood and urine


Secondary Outcome Measures :
  1. nutrition state [ Time Frame: 18 weeks ]
    As measured with the total score with Patient-Generated Subjective Global Assessment (PG/SGA).

  2. distress [ Time Frame: 18 weeks ]
    measured by the distress thermometer and problem list

  3. problems [ Time Frame: 18 weeks ]
    as measured with the problem list.(the mean of each item)

  4. change in quality of life [ Time Frame: 18 weeks ]
    determined by the QLQ-GINET21 (a NET-specific EORTC quality of life questionnaire) and the cancer-specific EORTC QLQ-C30,

  5. difference in the self-reported healthy eating pattern. [ Time Frame: 18 weeks ]
    as measured with a self-constructed scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143946


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Annemiek ME Walenkamp, MD, PhD University Medical Center Groningen

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Responsible Party: A.M.E. Walenkamp, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03143946     History of Changes
Other Study ID Numbers: 201600626
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by A.M.E. Walenkamp, University Medical Center Groningen:
neuroendocrine tumor
vitamin
diet

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs