Impact of Oral Diets on Postoperative Fluid Collection
BC1
Impact of Preoperative Oral Diets on Postoperative Fluid Collection After Axillary Lymphadenectomy
1 other identifier
interventional
400
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 25, 2021
CompletedFirst Posted
Study publicly available on registry
October 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedOctober 13, 2021
October 1, 2021
1.7 years
September 25, 2021
October 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Fluid collection
The volume of fluid collection after lymph nodes resection expressed in mililiters
6 months
Study Arms (4)
Immunonutrition
EXPERIMENTALOral immunonutrition containing arginine, omega-PUFAs and antioxidants
High-protein diet
ACTIVE COMPARATOROral nutrition with high-protein content
Standard nutrition
ACTIVE COMPARATOROral nutrition with standard ingredients
No intervention
NO INTERVENTIONNo intervention
Interventions
Oral immunonutrition containing arginine, omega-PUFAs and antioxidants
Eligibility Criteria
You may qualify if:
- confirmed breast cancer or melanoma
- scheduled surgery with axillary lymph nodes resection
- informed consent
- eligible for surgery
You may not qualify if:
- benign disease
- no consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Maria Sklodowska-Curie National Cancer Institute
Krakow, Malopolska, 31-115, Poland
Stanley Dudrick's Memorial Hospital
Skawina, 32-050, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stanislaw Klek, PhD
Stanley Dudrick's Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Unit
Study Record Dates
First Submitted
September 25, 2021
First Posted
October 6, 2021
Study Start
June 1, 2021
Primary Completion
January 31, 2023
Study Completion
March 31, 2023
Last Updated
October 13, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share