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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

Tracking Information
First Submitted Date  ICMJE March 14, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date March 15, 2019
Actual Study Start Date  ICMJE December 6, 2016
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
Rate of Adherence to protocol [ Time Frame: 15 days ]
Rate of adherence to prescribed oral nutritional support
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutritional Status in Retroperitoneal Sarcoma.
Official Title  ICMJE Perioperative Nutritional and Hemodinamic Support in Retroperitoneal Sarcoma Patients. A Phase II Prospective Feasibility Study.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Retroperitoneal Sarcoma
  • Malnutrition
Intervention  ICMJE Dietary Supplement: Oral Nutritional Support
Preoperative oral nutritional support is provided according to malnutrition grade
Study Arms  ICMJE 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.
Intervention: Dietary Supplement: Oral Nutritional Support
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2019)
35
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03877588
Other Study ID Numbers  ICMJE INT-91/16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Sponsor  ICMJE Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP