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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Oral Impact, Nestlé Health Science
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring Postoperative, Complications, Elective, Surgery, GI surgery, Immunonutrition, Immune-enhancing, Immune-modulating, Nutrition, Pancreatic cancer, Postoperative complications and length of hospital stay after major gastrointestinal (GI) elective surgery.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Surgical Gastroenterology Clinic C, Ward 2122, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oral Impact, Nestlé Health Science

Control

Arm Description

Oral Impact-arm receives the intervention the last 7 days prior to surgery

The control-arm receives no intervention but is treated according to the standard procedures

Outcomes

Primary Outcome Measures

Overall postoperative complications after major gastrointestinal (GI) elective surgery.

Secondary Outcome Measures

Length of hospital stay after major gastrointestinal (GI) elective surgery

Full Information

First Posted
February 7, 2013
Last Updated
December 20, 2013
Sponsor
University of Copenhagen
Collaborators
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01789073
Brief Title
Preoperative Oral Immunonutrition for Patients With Pancreatic Cancer Undergoing Elective Surgery - Effect on Complications and Length of Hospital Stay
Official Title
Randomized, Controlled Trial Investigating the Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Postoperative, Complications, Elective, Surgery, GI surgery, Immunonutrition, Immune-enhancing, Immune-modulating, Nutrition, Pancreatic cancer, Postoperative complications and length of hospital stay after major gastrointestinal (GI) elective surgery.

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Impact, Nestlé Health Science
Arm Type
Experimental
Arm Description
Oral Impact-arm receives the intervention the last 7 days prior to surgery
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control-arm receives no intervention but is treated according to the standard procedures
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Impact, Nestlé Health Science
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall postoperative complications after major gastrointestinal (GI) elective surgery.
Time Frame
Within the first 30 days after surgery
Secondary Outcome Measure Information:
Title
Length of hospital stay after major gastrointestinal (GI) elective surgery
Time Frame
Within the first 30 days after surgery
Other Pre-specified Outcome Measures:
Title
Weight stability, functional capability and patients´ satisfaction with the overall study course.
Time Frame
from recruitment and within 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens R Andersen, Chief Phys., Ass. Prof.
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgical Gastroenterology Clinic C, Ward 2122, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26943500
Citation
Gade J, Levring T, Hillingso J, Hansen CP, Andersen JR. The Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer--A Randomized Controlled Trial. Nutr Cancer. 2016;68(2):225-33. doi: 10.1080/01635581.2016.1142586. Epub 2016 Mar 4.
Results Reference
derived

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

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