NCT05069402

Brief Summary

The optimalisation of the health status of patients scheduled for major surgery has been considered to be the most important point of perioperative care, and nutritional intervention has been perceived a key point of that intervention. Immunomodulating diets were thought to reduce cmplications, hoever recent studies put that opnion in doubt. This study was designed to assess the actual clinical significance of oral immunonutrition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 13, 2026

Status Verified

October 1, 2021

Enrollment Period

4.3 years

First QC Date

September 25, 2021

Last Update Submit

January 10, 2026

Conditions

Complication,Postoperative

Outcome Measures

Primary Outcomes (2)

  • Surgical complications

    Number and type of surgical complications

    6 months

  • Infectious complications

    Number and type of infectious complications

    6 months

Secondary Outcomes (1)

  • Length of stay

    6 months

Study Arms (3)

Immunonutrition

EXPERIMENTAL

Oral immunonutrition containing arginine, omega-PUFAs and antioxidants

Dietary Supplement: Immunonutrition

High-protein diet

ACTIVE COMPARATOR

Oral nutrition with high-protein content

Dietary Supplement: High-protein

Standard nutrition

ACTIVE COMPARATOR

Oral nutrition with standard components

Dietary Supplement: Standard ONS

Interventions

ImmunonutritionDIETARY_SUPPLEMENT

diet with immunonutrients

Immunonutrition
High-proteinDIETARY_SUPPLEMENT

Oral nutrition with high-protein content

High-protein diet
Standard ONSDIETARY_SUPPLEMENT

Oral nutrition with standard ingredients

Standard nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • no sign of malnutrition (defined as one of the following unintentional weight loss by at least 10% or body mass index (BMI) \< 18),
  • good general status (Karnofsky Performance Index \> 80,
  • Eastern Cooperative Oncology Group (ECOG) grade 0 or 1);
  • no confirmed neoplastic dissemination no severe concomitant disease (heart, lung, kidney, liver failure, chronic obstructive pulmonary disease \[COPD\], coronary aortic bypass graft \[CABG\], etc.),
  • no history of known allergies or drug intolerance to analyzed substances.

You may not qualify if:

  • Patients malnourished or with metastatic disease,
  • pregnant,
  • in poor general status (Karnofsky \<80, Eastern Cooperative Oncology Group (ECOG) \> 1),
  • recent history of severe heart, lung, kidney or liver failure,
  • history of allergies or drug intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Narodowy Instytut Onkologii

Krakow, Malopolska, 31-115, Poland

Location

Stanley Dudrick's Memorial Hospital

Skawina, Malopolska, 32-050, Poland

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Stanislaw Klek, PhD

    Stanley Dudrick's Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The physician is unaware of the type of the intervention. The type of intervention is given by the independent person to dietitian instructing the patient how to use the product.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomisation into 4 arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Unit

Study Record Dates

First Submitted

September 25, 2021

First Posted

October 6, 2021

Study Start

September 1, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 13, 2026

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR
Time Frame
12 months
Access Criteria
any health professional

Locations

PL(2)