The Management of Neuroendocrine Tumours: A Nutritional Viewpoint.

NCT03592940 | Completed

• 1 other identifier: 201/17
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Mediterranean Diet; Neuroendocrine Tumours (NETs)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Body composition

  December 2017 to June 2018

Interventions

Mediterranean diet DIETARY_SUPPLEMENT

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• patients with neuroendocrine tumours (NETs)

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Silvia Savastano

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 19, 2018
• Study Start: November 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: June 30, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)