Impact of Oral Diets on Postoperative Fluid Collection | NCT05068882

Studies
Impact of Oral Diets on Postoperative Fluid Collection

NCT05068882

Sponsor

Stanley Dudrick's Memorial Hospital

Status

Unknown status

Last Update Posted

Oct 13, 2021Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Postoperative Complications

Interventions

Immunonutrition
High-protein nutrition
Standard nutrition

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Jan 31, 2023Estimated

Completion Date

Mar 31, 2023Estimated

First Submitted Date

Sep 25, 2021

First Submission Date that Met QC Criteria

Sep 25, 2021

First Posted Date

Oct 6, 2021Actual

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

Oct 5, 2021

Last Update Posted Date

Oct 13, 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)

Yes

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

Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.

Detailed Description

Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections, which requires either prolonged drainage or multiple punctuations. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 nutrition
Standard nutrition	Active Comparator	Oral nutrition with standard ingredients	Dietary Supplement: Standard nutrition
No intervention	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immunonutrition	Dietary Supplement	Oral immunonutrition containing arginine, omega-PUFAs and antioxidants	Immunonutrition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fluid collection	The volume of fluid collection after lymph nodes resection expressed in mililiters	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

confirmed breast cancer or melanoma
scheduled surgery with axillary lymph nodes resection
informed consent
eligible for surgery

Exclusion Criteria:

benign disease
no consent

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

Name	Role	Phone	Extension	Email
Stanislaw Klek, PhD	Contact	+48604293566		klek@poczta.onet.pl

Overall Officials

Name	Affiliation	Role
Stanislaw Klek, PhD	Stanley Dudrick's Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maria Sklodowska-Curie National Cancer Institute	Recruiting	Krakow	Malopolska	31-115	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
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000093702	Immunonutrition Diet

Ancestor Terms

ID	Term
D004032	Diet
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Double

Masking Description

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.

Who Masked

InvestigatorOutcomes Assessor