Postoperative Enteral Immunonutrition in Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Immunomodulating nutrition (Reconvan)
Standard nutrition (Peptisorb)
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring immunonutrition, gastric cancer, enteral nutrition
Eligibility Criteria
Inclusion Criteria:
- gastric cancer confirmed in histopathological examination
- elective operation due to gastric cancer
- informed consent signed
- age > 18 years
- normal nutritional status or mild to moderate malnutrition
Exclusion Criteria:
- severe malnutrition which required parenteral nutrition
- urgent operation
Sites / Locations
- 1st Department of General Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
Control group
Arm Description
Immunomodulating nutrition (Reconvan)
Standard nutrition (Peptisorb)
Outcomes
Primary Outcome Measures
Postoperative complication rate
Complication rate during 30 days after the operation
Secondary Outcome Measures
Overall survival
5-year overall survival
Full Information
NCT ID
NCT02647476
First Posted
January 1, 2016
Last Updated
February 25, 2019
Sponsor
Jagiellonian University
1. Study Identification
Unique Protocol Identification Number
NCT02647476
Brief Title
Postoperative Enteral Immunonutrition in Gastric Cancer
Official Title
The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.
The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.
The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 (Reconvan ,Fresenius Kabi), or standard enteral nutrition n=54 (Peptisorb, Nutricia). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.
Detailed Description
Treatment of gastric cancer often requires major surgery and carries the risk of postoperative complications and fatal outcomes. Mortality rates after gastrectomy due to gastric cancer have been reported as 2-5%, while the incidence of postoperative complications was 10 to over 40%.
Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.
The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.
The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 or standard enteral nutrition n=54. Following the initial randomization, the patients received either standard nutrition (oligopeptide, low-fat, isocaloric, non-residue diet - Peptisorb, Nutricia) or immunomodulating nutrition (protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
immunonutrition, gastric cancer, enteral nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Immunomodulating nutrition (Reconvan)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard nutrition (Peptisorb)
Intervention Type
Dietary Supplement
Intervention Name(s)
Immunomodulating nutrition (Reconvan)
Intervention Description
protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard nutrition (Peptisorb)
Intervention Description
oligopeptide, low-fat, isocaloric, non-residue diet
Primary Outcome Measure Information:
Title
Postoperative complication rate
Description
Complication rate during 30 days after the operation
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Overall survival
Description
5-year overall survival
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
gastric cancer confirmed in histopathological examination
elective operation due to gastric cancer
informed consent signed
age > 18 years
normal nutritional status or mild to moderate malnutrition
Exclusion Criteria:
severe malnutrition which required parenteral nutrition
urgent operation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radosław Pach, MD PhD
Organizational Affiliation
1st Dept. of General Surgery, Jagiellonian University
Official's Role
Study Chair
Facility Information:
Facility Name
1st Department of General Surgery
City
Kraków
State/Province
Malopolska
ZIP/Postal Code
31-501
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29533110
Citation
Scislo L, Pach R, Nowak A, Walewska E, Gadek M, Brandt P, Puto G, Szczepanik AM, Kulig J. The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients - Randomized Clinical Trial. Nutr Cancer. 2018 Apr;70(3):453-459. doi: 10.1080/01635581.2018.1445770. Epub 2018 Mar 13.
Results Reference
result
Links:
URL
https://doi.org/10.1016/j.pan.2018.09.008
Description
LInk to full text of the article with results summary
Learn more about this trial
Postoperative Enteral Immunonutrition in Gastric Cancer
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