Impact of Preoperative Oral Diets on Postoperative Fluid Collection After Axillary Lymphadenectomy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Fluid collection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Immunonutrition
Oral immunonutrition containing arginine, omega-PUFAs and antioxidants
Intervention: Immunonutrition (Dietary Supplement)
High-protein diet
Oral nutrition with high-protein content
Intervention: High-protein nutrition (Dietary Supplement)
Standard nutrition
Oral nutrition with standard ingredients
Intervention: Standard nutrition (Dietary Supplement)
No intervention
No intervention
Outcomes
Primary Outcomes
Fluid collection
Time Frame: 6 months
The volume of fluid collection after lymph nodes resection expressed in mililiters
Secondary Outcomes
No secondary outcomes reported
Investigators
Stanislaw Klek
Head of the Unit
Stanley Dudrick's Memorial Hospital