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Impact of Oral Diets on Postoperative Fluid Collection (BC1)

Primary Purpose

Postoperative Complications

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Immunonutrition
High-protein nutrition
Standard nutrition
Sponsored by
Stanley Dudrick's Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Complications

Eligibility Criteria

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

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

Sites / Locations

  • Maria Sklodowska-Curie National Cancer InstituteRecruiting
  • Stanley Dudrick's Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

Immunonutrition

High-protein diet

Standard nutrition

No intervention

Arm Description

Oral immunonutrition containing arginine, omega-PUFAs and antioxidants

Oral nutrition with high-protein content

Oral nutrition with standard ingredients

No intervention

Outcomes

Primary Outcome Measures

Fluid collection
The volume of fluid collection after lymph nodes resection expressed in mililiters

Secondary Outcome Measures

Full Information

First Posted
September 25, 2021
Last Updated
October 5, 2021
Sponsor
Stanley Dudrick's Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05068882
Brief Title
Impact of Oral Diets on Postoperative Fluid Collection
Acronym
BC1
Official Title
Impact of Preoperative Oral Diets on Postoperative Fluid Collection After Axillary Lymphadenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

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
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
4 arm randomized study
Masking
InvestigatorOutcomes Assessor
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.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immunonutrition
Arm Type
Experimental
Arm Description
Oral immunonutrition containing arginine, omega-PUFAs and antioxidants
Arm Title
High-protein diet
Arm Type
Active Comparator
Arm Description
Oral nutrition with high-protein content
Arm Title
Standard nutrition
Arm Type
Active Comparator
Arm Description
Oral nutrition with standard ingredients
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Immunonutrition
Intervention Description
Oral immunonutrition containing arginine, omega-PUFAs and antioxidants
Intervention Type
Dietary Supplement
Intervention Name(s)
High-protein nutrition
Intervention Description
Oral nutrition with high-protein content
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard nutrition
Intervention Description
Oral nutrition with standard ingredients
Primary Outcome Measure Information:
Title
Fluid collection
Description
The volume of fluid collection after lymph nodes resection expressed in mililiters
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stanislaw Klek, PhD
Phone
+48604293566
Email
klek@poczta.onet.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislaw Klek, PhD
Organizational Affiliation
Stanley Dudrick's Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Sklodowska-Curie National Cancer Institute
City
Kraków
State/Province
Malopolska
ZIP/Postal Code
31-115
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Narodowy I Onkologii
Phone
60293566
Email
stanislaw.klek@onkologia.krakow.pl
Facility Name
Stanley Dudrick's Memorial Hospital
City
Skawina
ZIP/Postal Code
32-050
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanislaw Klek, Assoc. Prof.
Phone
+48604293566
Email
klek@poczta.onet.pl
First Name & Middle Initial & Last Name & Degree
Stanislaw Klek, Assoc. Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Oral Diets on Postoperative Fluid Collection

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