The Management of Neuroendocrine Tumours: A Nutritional Viewpoint.

Mediterranean Diet Clinical Trial

— NetNutr  

Official title:

Association Between Mediterranean Diet and Neuroendocrine Tumours.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592940
• Other study ID #: 201/17
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2018
• Est. primary completion date: December 1, 2017
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients with neuroendocrine tumours (NETs)

Exclusion Criteria:

• age>65 years

• < BMI 19 kg/m2

• vegetarians

Related Conditions & MeSH terms

• Mediterranean Diet
• Neuroendocrine Tumors
• Neuroendocrine Tumours (NETs)

Intervention

Dietary Supplement:
• Mediterranean diet
We aim to determine the effects of the traditional Mediterranean Diet on neuroendocrine tumours

Locations

Country	Name	City	State
Italy	Silvia Savastano	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Mediterranean Diet by Predimed Questionnaire	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	Body composition	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