Preoperative High Protein vs Immunodiet in Surgical Cance... | NCT03980704

Studies
Preoperative High Protein vs Immunodiet in Surgical Cancer Patients

NCT03980704

Sponsor

Stanley Dudrick's Memorial Hospital

Status

Completed

Last Update Posted

Jul 26, 2021Actual

Enrollment

299Actual

Phase

Phase 4

Conditions

General Surgery
Cancer of Colon

Interventions

IMPACT
resource protein

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Mar 31, 2021Actual

First Submitted Date

Jun 5, 2019

First Submission Date that Met QC Criteria

Jun 7, 2019

First Posted Date

Jun 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2021

Last Update Posted Date

Jul 26, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stanislaw Klek, Head of the Unit, Stanley Dudrick's Memorial HospitalPrincipal Investigator

Lead Sponsor

Stanley Dudrick's Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

299Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High Protein	Active Comparator	Provision of 400 ml per day of high protein oral nutritional supplements	Drug: resource protein
Immuno ONS	Experimental	Provision of 400 ml per day of immunostimulating oral nutritional supplements	Drug: IMPACT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IMPACT	Drug	Administration of oral immunostimulating oral supplement	Immuno ONS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infectious complications	Number and type of infectious complications	6 months

Secondary Outcomes

Measure	Description	Time Frame
Surgical complications	Number and type of surgical complications	6 months
Length of stay	Hospital length of stay	14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

resectable GI cancer
written consent

Exclusion Criteria:

inoperable GI cancer
known allergy to the drug

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stanislaw Klek	Stanley Dudrick's Memorial Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanley Dudrick's Memorial Hospital		Skawina		32-050	Poland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided