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

Cancer Clinical Trial

— PaNCS  

Official title:

Early Versus Late Parenteral Nutrition in Cancer Patients Undergoing Abdominal Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01839617
• Other study ID #: ICESP
• Status: Active, not recruiting
• Phase: N/A
• First received: April 22, 2013
• Last updated: February 5, 2018
• Start date: May 7, 2013
• Est. completion date: April 10, 2018

Study information

• Verified date: February 2018
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 335
• Est. completion date: April 10, 2018
• Est. primary completion date: June 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Surgery
• Cancer
• Parenteral Nutrition

Intervention

Dietary Supplement:
• Early parenteral nutrition

• Late parenteral nutrition

Locations

Country	Name	City	State
Brazil	ICESP	Sao Paulo	SP
Brazil	Cancer Institute of the State of Sao Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical complications	respiratory, cardiovascular, renal, neurological, infectious, surgical	30 days
Secondary	Mortality	30-day mortality	30 days
Secondary	Length of stay in ICU and in hospital	Length of stay	30 days
Secondary	ICU readmission rate	ICU readmission rate	30 days
Secondary	Duration of pharmacologic hemodynamic support	duration of vasopressor therapy	30 days
Secondary	Levels of C-reactive protein	serum levels of C-reactive protein	7 days
Secondary	Duration of mechanical ventilation	Duration of invasive mechanical ventilation	30 days
Secondary	Liver dysfunction	liver dysfunction according SOFA	30 days