NetNutr: The Management of Neuroendocrine Tumours: A Nutritional Viewpoint.

• Sponsor: Federico II University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03592940
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 7.9
• Patients Per Site Per Month: 12.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Mediterranean Diet; Neuroendocrine Tumours (NETs)	Dietary Supplement: Mediterranean diet

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Association Between Mediterranean Diet and Neuroendocrine Tumours.
• Actual Study Start Date: Nov 1, 2017
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Jun 30, 2018

Outcome Measures

Primary Outcome Measures

1. Adherence to Mediterranean Diet by Predimed Questionnaire [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)

Secondary Outcome Measures

1. Body composition [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• patients with neuroendocrine tumours (NETs)

Exclusion Criteria:

• age>65 years

• < BMI 19 kg/m2

• vegetarians

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Silvia Savastano	Naples		Italy	80131

Sponsors and Collaborators

• Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Silvia Savastano, Associate Professor, Federico II University
• ClinicalTrials.gov Identifier: NCT03592940
• Other Study ID Numbers: 201/17
• First Posted: Jul 19, 2018
• Last Update Posted: Jul 19, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neuroendocrine Tumors

Study Results

No Results Posted as of Jul 19, 2018