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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Instituto do Cancer do Estado de São Paulo
Sponsor:
Information provided by (Responsible Party):
Patrícia Camargo Marques, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT01839617
First received: April 22, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Cancer
Abdominal Surgery
Parenteral Nutrition
Dietary Supplement: Early parenteral nutrition
Dietary Supplement: Late parenteral nutrition
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Versus Late Parenteral Nutrition in Cancer Patients Undergoing Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by Instituto do Cancer do Estado de São Paulo:

Primary Outcome Measures:
  • Clinical complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    respiratory, cardiovascular, renal, neurological, infectious, surgical


Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    30-day mortality

  • Length of stay in ICU and in hospital [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Length of stay

  • ICU readmission rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Duration of pharmacologic hemodynamic support [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Levels of C-reactive protein [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Duration of mechanical ventilation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Liver dysfunction [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 335
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839617

Contacts
Contact: Patricia C Marques, MD 11-38933271

Locations
Brazil
ICESP Recruiting
Sao Paulo, SP, Brazil, 01414001
Principal Investigator: Patricia C Moraes, MD         
Sub-Investigator: Ludhmila A Hajjar, PhD         
Cancer Institute of the State of Sao Paulo Not yet recruiting
São Paulo, SP, Brazil, 01246-000
Contact: PATRÍCIA CAMARGO MARQUES UIC    +55 11 3893-3267    patipaticamar@hotmail.com   
Contact: ICESP UIC    +55 11 3893-3267    marcia.franca@icesp.org.br   
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
  More Information

No publications provided

Responsible Party: Patrícia Camargo Marques, Principal Investigator, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT01839617     History of Changes
Other Study ID Numbers: ICESP
Study First Received: April 22, 2013
Last Updated: October 28, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto do Cancer do Estado de São Paulo:
parenteral nutrition
early nutrition
abdominal surgery
cancer

ClinicalTrials.gov processed this record on August 18, 2014