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NCT05068882 Clinical Trial

Impact of Oral Diets on Postoperative Fluid Collection

Postoperative Complications Clinical Trial

— BC1  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05068882
Other study ID # BC1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date March 31, 2023

Study information
Verified date October 2021
Source Stanley Dudrick's Memorial Hospital
Contact Stanislaw Klek, PhD
Phone +48604293566
Email klek@poczta.onet.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date March 31, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Immunonutrition
Oral immunonutrition containing arginine, omega-PUFAs and antioxidants
• High-protein nutrition
Oral nutrition with high-protein content
• Standard nutrition
Oral nutrition with standard ingredients

Locations
Country Name City State
Poland Maria Sklodowska-Curie National Cancer Institute Kraków Malopolska
Poland Stanley Dudrick's Memorial Hospital Skawina

Sponsors (1)
Lead Sponsor Collaborator
Stanley Dudrick's Memorial Hospital

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fluid collection The volume of fluid collection after lymph nodes resection expressed in mililiters 6 months
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