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Preop immuno: Preoperative High Protein vs Immunodiet in Surgical Cancer Patients

Sponsor
Stanley Dudrick's Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03980704
Collaborator
(none)
299
Enrollment
1
Location
2
Arms
24
Actual Duration (Months)
12.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
299 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled trialrandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Preoperative Use of the High Protein ONS vs Immunoenhancing ONS in Gastrointestinal Cancer Patients Undergoing Surgery
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: High Protein

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

Drug: resource protein
Administration of oral high-protein oral supplement
Experimental: Immuno ONS

Provision of 400 ml per day of immunostimulating oral nutritional supplements

Drug: IMPACT
Administration of oral immunostimulating oral supplement

Outcome Measures

Primary Outcome Measures

  1. Infectious complications [6 months]

    Number and type of infectious complications

Secondary Outcome Measures

  1. Surgical complications [6 months]

    Number and type of surgical complications

  2. Length of stay [14 days]

    Hospital length of stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • resectable GI cancer

  • written consent

Exclusion Criteria:

  • inoperable GI cancer

  • known allergy to the drug

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanley Dudrick's Memorial Hospital Skawina Poland 32-050

Sponsors and Collaborators

  • Stanley Dudrick's Memorial Hospital

Investigators

  • Study Director: Stanislaw Klek, Stanley Dudrick's Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stanislaw Klek, Head of the Unit, Stanley Dudrick's Memorial Hospital
ClinicalTrials.gov Identifier:
NCT03980704
Other Study ID Numbers:
  • Imm1
First Posted:
Jun 10, 2019
Last Update Posted:
Jul 26, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stanislaw Klek, Head of the Unit, Stanley Dudrick's Memorial Hospital
immunonutrition
preoperative nutrition
Additional relevant MeSH terms:
Colonic Neoplasms

Study Results

No Results Posted as of Jul 26, 2021