Impact of Oral Diets on Postoperative Fluid Collection (BC1)

Impact of Preoperative Oral Diets on Postoperative Fluid Collection After Axillary Lymphadenectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications
• Intervention / Treatment: Dietary supplement: Immunonutrition; Dietary supplement: High-protein nutrition; Dietary supplement: Standard nutrition

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Skawina, Poland, 32-050
    • Recruiting
    • Stanley Dudrick's Memorial Hospital
    • Contact: Stanislaw Klek, Assoc. Prof.; Phone Number: +48604293566; Email: klek@poczta.onet.pl
    • Principal Investigator: Stanislaw Klek, Assoc. Prof.
  • Malopolska
    • Kraków, Malopolska, Poland, 31-115
      • Recruiting
      • Maria Sklodowska-Curie National Cancer Institute
      • Contact: Narodowy I Onkologii; Phone Number: 60293566; Email: stanislaw.klek@onkologia.krakow.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention
Experimental: Immunonutrition; Oral immunonutrition containing arginine, omega-PUFAs and antioxidants	Dietary supplement: Immunonutrition; Oral immunonutrition containing arginine, omega-PUFAs and antioxidants
Active Comparator: High-protein diet; Oral nutrition with high-protein content	Dietary supplement: High-protein nutrition; Oral nutrition with high-protein content
Active Comparator: Standard nutrition; Oral nutrition with standard ingredients	Dietary supplement: Standard nutrition; Oral nutrition with standard ingredients

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanley Dudrick's Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: September 25, 2021
• First Submitted That Met QC Criteria: September 25, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: BC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No