Study Comparing Early and Late Nutrition in Cancer Patients Undergoing Abdominal Surgery (PaNCS)
|ClinicalTrials.gov Identifier: NCT01839617|
Recruitment Status : Active, not recruiting
First Posted : April 25, 2013
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment|
|Cancer Abdominal Surgery Parenteral Nutrition||Dietary Supplement: Early parenteral nutrition Dietary Supplement: Late parenteral nutrition|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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|
- Clinical complications [ Time Frame: 30 days ]respiratory, cardiovascular, renal, neurological, infectious, surgical
- 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 ]ICU readmission rate
- Duration of pharmacologic hemodynamic support [ Time Frame: 30 days ]duration of vasopressor therapy
- Levels of C-reactive protein [ Time Frame: 7 days ]serum levels of C-reactive protein
- Duration of mechanical ventilation [ Time Frame: 30 days ]Duration of invasive mechanical ventilation
- Liver dysfunction [ Time Frame: 30 days ]liver dysfunction according SOFA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839617
|Sao Paulo, SP, Brazil, 01414001|
|Cancer Institute of the State of Sao Paulo|
|São Paulo, SP, Brazil, 01246-000|
|Principal Investigator:||Patricia Marques, MD||Instituto do Cancer do Estado de São Paulo|