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OpenTrials
Completed

NCT Number: NCT03592940

The Management of Neuroendocrine Tumours: A Nutritional Viewpoint.

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.

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Key information

Conditions

Mediterranean Diet Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Neuroendocrine Tumours (NETs)

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Silvia Savastano

Naples, 80131, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with neuroendocrine tumours (NETs)

Exclusion criteria

  • age>65 years
  • < BMI 19 kg/m2
  • vegetarians

Treatment and study plan

Mediterranean diet

Dietary Supplement

We aim to determine the effects of the traditional Mediterranean Diet on neuroendocrine tumours

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Association Between Mediterranean Diet and Neuroendocrine Tumours.

Acronym: NetNutr

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 19, 2018
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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