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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Patrícia Camargo Marques, Instituto do Cancer do Estado de São Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01839617
First Posted: April 25, 2013
Last Update Posted: October 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Patrícia Camargo Marques, Instituto do Cancer do Estado de São Paulo
  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 (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 Patrícia Camargo Marques, Instituto do Cancer do Estado de São Paulo:

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


Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 days ]
    30-day mortality

  • Length of stay in ICU and in hospital [ Time Frame: 30 days ]
    Length of stay

  • ICU readmission rate [ Time Frame: 30 days ]
  • Duration of pharmacologic hemodynamic support [ Time Frame: 30 days ]
  • Levels of C-reactive protein [ Time Frame: 7 days ]
  • Duration of mechanical ventilation [ Time Frame: 30 days ]
  • Liver dysfunction [ Time Frame: 30 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 22, 2013
First Posted: April 25, 2013
Last Update Posted: October 29, 2013
Last Verified: October 2013

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