search
Back to results

Preoperative High Protein vs Immunodiet in Surgical Cancer Patients (Preop immuno)

Primary Purpose

General Surgery, Cancer of Colon

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
IMPACT
resource protein
Sponsored by
Stanley Dudrick's Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for General Surgery focused on measuring immunonutrition, preoperative nutrition

Eligibility Criteria

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

Inclusion Criteria:

  • resectable GI cancer
  • written consent

Exclusion Criteria:

  • inoperable GI cancer
  • known allergy to the drug

Sites / Locations

  • Stanley Dudrick's Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

High Protein

Immuno ONS

Arm Description

Provision of 400 ml per day of high protein oral nutritional supplements

Provision of 400 ml per day of immunostimulating oral nutritional supplements

Outcomes

Primary Outcome Measures

Infectious complications
Number and type of infectious complications

Secondary Outcome Measures

Surgical complications
Number and type of surgical complications
Length of stay
Hospital length of stay

Full Information

First Posted
June 5, 2019
Last Updated
July 23, 2021
Sponsor
Stanley Dudrick's Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03980704
Brief Title
Preoperative High Protein vs Immunodiet in Surgical Cancer Patients
Acronym
Preop immuno
Official Title
Preoperative Use of the High Protein ONS vs Immunoenhancing ONS in Gastrointestinal Cancer Patients Undergoing Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanley Dudrick's Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.
Detailed Description
Between March 1, 2019, and December 31, 2020, a group of 300 well-nourished patients will be enrolled to the study and randomly assigned two one of two groups: A-high protein oral supplements (ONS) and B- immunomodulating ONS. The study is designed to test the hypothesis that immunonutrition and reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Surgery, Cancer of Colon
Keywords
immunonutrition, preoperative nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Protein
Arm Type
Active Comparator
Arm Description
Provision of 400 ml per day of high protein oral nutritional supplements
Arm Title
Immuno ONS
Arm Type
Experimental
Arm Description
Provision of 400 ml per day of immunostimulating oral nutritional supplements
Intervention Type
Drug
Intervention Name(s)
IMPACT
Intervention Description
Administration of oral immunostimulating oral supplement
Intervention Type
Drug
Intervention Name(s)
resource protein
Intervention Description
Administration of oral high-protein oral supplement
Primary Outcome Measure Information:
Title
Infectious complications
Description
Number and type of infectious complications
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Surgical complications
Description
Number and type of surgical complications
Time Frame
6 months
Title
Length of stay
Description
Hospital length of stay
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: resectable GI cancer written consent Exclusion Criteria: inoperable GI cancer known allergy to the drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislaw Klek
Organizational Affiliation
Stanley Dudrick's Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Stanley Dudrick's Memorial Hospital
City
Skawina
ZIP/Postal Code
32-050
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preoperative High Protein vs Immunodiet in Surgical Cancer Patients

We'll reach out to this number within 24 hrs