NCT03877588

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

March 14, 2019

Last Update Submit

March 14, 2019

Conditions

Retroperitoneal SarcomaMalnutrition

Outcome Measures

Primary Outcomes (1)

  • Rate of Adherence to protocol

    Rate of adherence to prescribed oral nutritional support

    15 days

Study Arms (1)

Primary retroperitoneal sarcoma

OTHER

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

Interventions

Oral Nutritional SupportDIETARY_SUPPLEMENT

Preoperative oral nutritional support is provided according to malnutrition grade

Primary retroperitoneal sarcoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- every patient with retroperitoneal sarcoma scheduled for surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31848820DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

Nutritional Support

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 15, 2019

Study Start

December 6, 2016

Primary Completion

June 30, 2018

Study Completion

November 30, 2018

Last Updated

March 15, 2019

Record last verified: 2019-03