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Nutritional Status in Retroperitoneal Sarcoma. (NOVA)

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ClinicalTrials.gov Identifier: NCT03877588
Recruitment Status : Completed
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:
Prospective feasibility study of perioperative nutrition in patients affected by primary retroperitoneal sarcoma

Condition or disease Intervention/treatment Phase
Retroperitoneal Sarcoma Malnutrition Dietary Supplement: Oral Nutritional Support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Perioperative Nutritional and Hemodinamic Support in Retroperitoneal Sarcoma Patients. A Phase II Prospective Feasibility Study.
Actual Study Start Date : December 6, 2016
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : November 30, 2018


Arm Intervention/treatment
Primary retroperitoneal sarcoma
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.
Dietary Supplement: Oral Nutritional Support
Preoperative oral nutritional support is provided according to malnutrition grade




Primary Outcome Measures :
  1. Rate of Adherence to protocol [ Time Frame: 15 days ]
    Rate of adherence to prescribed oral nutritional support



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT03877588     History of Changes
Other Study ID Numbers: INT-91/16
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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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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Sarcoma
Malnutrition
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Nutrition Disorders