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Trial record 86 of 2726 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

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

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ClinicalTrials.gov Identifier: NCT03592940
Recruitment Status : Completed
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Silvia Savastano, Federico II University

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
Mediterranean Diet Neuroendocrine Tumours (NETs) Dietary Supplement: Mediterranean diet

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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 : November 1, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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.
Criteria

Inclusion Criteria:

  • patients with neuroendocrine tumours (NETs)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592940


Locations
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Italy
Silvia Savastano
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University

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Responsible Party: Prof. Silvia Savastano, Associate Professor, Federico II University
ClinicalTrials.gov Identifier: NCT03592940     History of Changes
Other Study ID Numbers: 201/17
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue