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

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ClinicalTrials.gov Identifier: NCT01839617
Recruitment Status : Active, not recruiting
First Posted : April 25, 2013
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Patrícia Camargo Marques, Instituto do Cancer do Estado de São Paulo

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

Condition or disease Intervention/treatment
Cancer Abdominal Surgery Parenteral Nutrition Dietary Supplement: Early parenteral nutrition 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
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
Actual Study Start Date : May 7, 2013
Primary Completion Date : June 27, 2016
Estimated Study Completion Date : April 10, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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


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

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

  3. ICU readmission rate [ Time Frame: 30 days ]
    ICU readmission rate

  4. Duration of pharmacologic hemodynamic support [ Time Frame: 30 days ]
    duration of vasopressor therapy

  5. Levels of C-reactive protein [ Time Frame: 7 days ]
    serum levels of C-reactive protein

  6. Duration of mechanical ventilation [ Time Frame: 30 days ]
    Duration of invasive mechanical ventilation

  7. Liver dysfunction [ Time Frame: 30 days ]
    liver dysfunction according SOFA



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.

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


Locations
Brazil
ICESP
Sao Paulo, SP, Brazil, 01414001
Cancer Institute of the State of Sao Paulo
São Paulo, SP, Brazil, 01246-000
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Investigators
Principal Investigator: Patricia Marques, MD Instituto do Cancer do Estado de São Paulo

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 Posted: April 25, 2013    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Product Manufactured in and Exported from the U.S.: Yes

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