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Nutritional Status in Retroperitoneal Sarcoma. (NOVA)

Primary Purpose

Retroperitoneal Sarcoma, Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral Nutritional Support
Sponsored by
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Retroperitoneal Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- every patient with retroperitoneal sarcoma scheduled for surgery

Exclusion Criteria:

  • chronic renal failure
  • diabetes mellitus
  • emergency surgery
  • physical status classification system ASA>3
  • any contraindication to arterial catheter in Femoral artery for PICCO hemodynamic monitoring

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Primary retroperitoneal sarcoma

    Arm Description

    All eligible patients are screened in preoperative phase, at least 30 days before surgery, for presence of protein energetic malnutrition (PEM). PEM is defined according to biochemical and physiological parameters (Table). 3 class of PEM are identified: no PEM, mild PEM and serious PEM. Different nutritional oral supplements are provided according to the degree of malnutrition.

    Outcomes

    Primary Outcome Measures

    Rate of Adherence to protocol
    Rate of adherence to prescribed oral nutritional support

    Secondary Outcome Measures

    Full Information

    First Posted
    March 14, 2019
    Last Updated
    March 14, 2019
    Sponsor
    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03877588
    Brief Title
    Nutritional Status in Retroperitoneal Sarcoma.
    Acronym
    NOVA
    Official Title
    Perioperative Nutritional and Hemodinamic Support in Retroperitoneal Sarcoma Patients. A Phase II Prospective Feasibility Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 6, 2016 (Actual)
    Primary Completion Date
    June 30, 2018 (Actual)
    Study Completion Date
    November 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Prospective feasibility study of perioperative nutrition in patients affected by primary retroperitoneal sarcoma
    Detailed Description
    Aim of our study was to investigate the feasibility of a prehabilitation policy to optimize protein energetic reserves in a group of patients affected by primary localized RPS, candidate to a multiple organ resection surgery, as well as the feasibility of a standardized nutritional postoperative caloric target and its adequacy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retroperitoneal Sarcoma, Malnutrition

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Primary retroperitoneal sarcoma
    Arm Type
    Other
    Arm Description
    All eligible patients are screened in preoperative phase, at least 30 days before surgery, for presence of protein energetic malnutrition (PEM). PEM is defined according to biochemical and physiological parameters (Table). 3 class of PEM are identified: no PEM, mild PEM and serious PEM. Different nutritional oral supplements are provided according to the degree of malnutrition.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Oral Nutritional Support
    Intervention Description
    Preoperative oral nutritional support is provided according to malnutrition grade
    Primary Outcome Measure Information:
    Title
    Rate of Adherence to protocol
    Description
    Rate of adherence to prescribed oral nutritional support
    Time Frame
    15 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - every patient with retroperitoneal sarcoma scheduled for surgery Exclusion Criteria: chronic renal failure diabetes mellitus emergency surgery physical status classification system ASA>3 any contraindication to arterial catheter in Femoral artery for PICCO hemodynamic monitoring

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31848820
    Citation
    Previtali P, Fiore M, Colombo J, Arendar I, Fumagalli L, Pizzocri M, Colombo C, Rampello NN, Mariani L, Gronchi A, Codazzi D. Malnutrition and Perioperative Nutritional Support in Retroperitoneal Sarcoma Patients: Results from a Prospective Study. Ann Surg Oncol. 2020 Jun;27(6):2025-2032. doi: 10.1245/s10434-019-08121-0. Epub 2019 Dec 17.
    Results Reference
    derived

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    Nutritional Status in Retroperitoneal Sarcoma.

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