The Management of Neuroendocrine Tumours: A Nutritional Viewpoint. (NetNutr)
July 10, 2018 updated by: Prof. Silvia Savastano, Federico II University
Association Between Mediterranean Diet and Neuroendocrine Tumours.
Nutritional status in patients with neuroendocrine tumours (NETs), especially of gastroenteropancreatic origin, can be deeply affected by excessive production of gastrointestinal hormones, peptides, and amines, which can lead to malabsorption, diarrhoea, steatorrhea, and altered gastrointestinal motility.
Besides, the surgical and/or medical management of NETs can lead to alteration of gastrointestinal secretory, motor, and absorptive functions, with both dietary and nutritional consequences.
Indeed, disease-related malnutrition is a frequently encountered yet both underrecognized and understudied clinical phenomenon in patients with NETs, with substantial prognostic and socioeconomic consequences.
Most of these conditions can be alleviated by a tailored nutritional approach, also with the aim of improving the efficacy of cancer treatments.
In this setting, skilled nutritionists can play a fundamental role in the multidisciplinary health care team in NETs management and their presence should be recommended.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Naples, Italy, 80131
- Silvia Savastano
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
One hundred patients with neuroendocrine tumours (NETs) were consecutively enrolled (aged 18-60 years) in this cross-sectional observational study.
Anthropometric measures were evaluated.
A validated 14-item questionnaire PREDIMED (PREvención con DIeta MEDiterránea) was used for the assessment of adherence to the MD.
Dietary data were collected by a 7-day food records.
Description
Inclusion Criteria:
- patients with neuroendocrine tumours (NETs)
Exclusion Criteria:
- age>65 years
- < BMI 19 kg/m2
- vegetarians
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to Mediterranean Diet by Predimed Questionnaire
Time Frame: December 2017 to June 2018
|
Validated 14-item tool of adherence to the Mediterranean diet, with three categories of adherence (≤5, low adherence, 6-9, average adherence and ≥10 points, high adherence)
|
December 2017 to June 2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body composition
Time Frame: December 2017 to June 2018
|
BIA was performed using a BIA phase-sensitive system by experienced observers (an 800-µA current at a frequency single-frequency of 50 kHz BIA 101 RJL, Akern Bioresearch, Florence, Italy)
|
December 2017 to June 2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2017
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
June 30, 2018
Study Registration Dates
First Submitted
July 10, 2018
First Submitted That Met QC Criteria
July 10, 2018
First Posted (Actual)
July 19, 2018
Study Record Updates
Last Update Posted (Actual)
July 19, 2018
Last Update Submitted That Met QC Criteria
July 10, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.