NCT02481804

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

January 6, 2015

Last Update Submit

May 3, 2024

Conditions

Neuroendocrine Tumor

Keywords

dietvitamin

Outcome Measures

Primary Outcomes (1)

  • gastro-intestinal symptoms

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

    18 weeks

Secondary Outcomes (5)

  • distress

    18 weeks

  • quality of life

    18 weeks

  • empowerment at end of study

    18 weeks

  • nutrition state

    18 weeks

  • vitamins and tryptophan levels

    18 weeks

Study Arms (1)

Dietary intervention

EXPERIMENTAL

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 interventionOther: Standard treatment

Interventions

Dietary interventionOTHER

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 treatmentOTHER

Standard treatment will be continued

Dietary intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • A. M.E. Walenkamp, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2015

First Posted

June 25, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 6, 2024

Record last verified: 2024-05

Locations

NL(1)