Preoperative Oral Immunonutrition for Patients With Pancreatic Cancer Undergoing Elective Surgery - Effect on Complications and Length of Hospital Stay

December 20, 2013 updated by: Arne Astrup, University of Copenhagen

Randomized, Controlled Trial Investigating the Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer

The purpose of this study is to investigate the effect of preoperative immunonutrition on complications and length of hospital stay in patients with pancreatic cancer undergoing elective surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Surgical Gastroenterology Clinic C, Ward 2122, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women referred to treatment at Surgical Gastroenterology Clinic C, Ward 2122 for pancreatic cancer
  • Age > 18 years.

Exclusion Criteria:

  • Age < 18 years
  • Pregnant and lactating women
  • Persons who cannot understand and/or speak Danish
  • Renal dysfunction
  • Milk allergy
  • Participants are excluded if elective surgery is not indicated after all

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Impact, Nestlé Health Science
Oral Impact-arm receives the intervention the last 7 days prior to surgery
Dietary supplement: Oral Impact, Nestlé Health Science
Oral Impact from Nestlé Health Science. An enteral nutritional supplement high in protein and with added immune-enhancing nutrients: arginine, fish oil and nucleotides. The intervention arm receives Oral Impact in an individually estimated dosage according to a protein requirement of 1.5 g/kg bodyweight/day (subtracted their habitual protein intake). Each patient receives this dosage orally the last 7 days prior to surgery.
No Intervention: Control
The control-arm receives no intervention but is treated according to the standard procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall postoperative complications after major gastrointestinal (GI) elective surgery.
Time Frame: Within the first 30 days after surgery
Within the first 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay after major gastrointestinal (GI) elective surgery
Time Frame: Within the first 30 days after surgery
Within the first 30 days after surgery

Other Outcome Measures

Outcome Measure
Time Frame
Weight stability, functional capability and patients´ satisfaction with the overall study course.
Time Frame: from recruitment and within 30 days after surgery
from recruitment and within 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Jens R Andersen, Chief Phys., Ass. Prof., University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 7, 2013

First Submitted That Met QC Criteria

February 8, 2013

First Posted (Estimate)

February 11, 2013

Study Record Updates

Last Update Posted (Estimate)

December 23, 2013

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2012-146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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