Study Comparing Early and Late Nutrition in Cancer Patients Undergoing Abdominal Surgery (PaNCS)

February 5, 2018 updated by: Patrícia Camargo Marques, Instituto do Cancer do Estado de São Paulo

Early Versus Late Parenteral Nutrition in Cancer Patients Undergoing Abdominal Surgery

The aim of this study is to find which is the best nutritional strategy in cancer patients undergoing abdominal surgery regarding postoperative complications.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There is a controversy regarding the timing of initiation of parenteral nutrition in cancer patients undergoing abdominal surgery in whom caloric targets cannot be met by enteral nutrition alone.

This is a randomized and controlled trial comparing early initiation with late initiation of parenteral nutrition.

Early-initiation group: patients will be randomized to initiate parenteral nutrition in the 2nd day after surgery.

Late-initiation group: patients will be randomized to initiate parenteral nutrition in the 7th day after surgery.

Calculations regarding the caloric goal included protein energy and were based on corrected ideal body weight, age and sex. When oral or enteral nutrition covered 80% of the calculated caloric goal, parenteral nutrition was reduced and progressively stopped.

Study Type

Interventional

Enrollment (Actual)

335

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 01414001
        • ICESP
      • São Paulo, SP, Brazil, 01246-000
        • Cancer Institute of the State of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Older than 18 years
  • Laparotomy for abdominal cancer surgery: urological, gynecological, digestive, abdominal sarcomas and melanomas, lymphomas and abdominal vascular.
  • Informed consent form signed by the patient or legal guardian.

Exclusion Criteria:

  • Reoperation within one year from the previous surgery. using previously parenteral nutrition.
  • Participation in another research protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early parenteral nutrition
Parenteral nutrition starts at 2nd postoperative day.
Dietary supplement: Early parenteral nutrition
Active Comparator: Late parenteral nutrition
Parenteral nutrition starts at 7th postoperative day.
Dietary supplement: Late parenteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical complications
Time Frame: 30 days
respiratory, cardiovascular, renal, neurological, infectious, surgical
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
30-day mortality
30 days
Length of stay in ICU and in hospital
Time Frame: 30 days
Length of stay
30 days
ICU readmission rate
Time Frame: 30 days
ICU readmission rate
30 days
Duration of pharmacologic hemodynamic support
Time Frame: 30 days
duration of vasopressor therapy
30 days
Levels of C-reactive protein
Time Frame: 7 days
serum levels of C-reactive protein
7 days
Duration of mechanical ventilation
Time Frame: 30 days
Duration of invasive mechanical ventilation
30 days
Liver dysfunction
Time Frame: 30 days
liver dysfunction according SOFA
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Investigators

  • Principal Investigator: Patricia Marques, MD, Instituto do Cancer do Estado de Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2013

Primary Completion (Actual)

June 27, 2016

Study Completion (Anticipated)

April 10, 2018

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ICESP

Drug and device information, study documents

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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