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Impact of Oral Diets on Postoperative Fluid Collection

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05068882
Acronym
BC1
Enrollment
400
Registered
2021-10-06
Start date
2021-06-01
Completion date
2023-03-31
Last updated
2021-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

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.

Interventions

DIETARY_SUPPLEMENTImmunonutrition

Oral immunonutrition containing arginine, omega-PUFAs and antioxidants

DIETARY_SUPPLEMENTHigh-protein nutrition

Oral nutrition with high-protein content

DIETARY_SUPPLEMENTStandard nutrition

Oral nutrition with standard ingredients

Sponsors

Stanley Dudrick's Memorial Hospital
Lead SponsorOTHER

Study design

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.

Intervention model description

4 arm randomized study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Fluid collection6 monthsThe volume of fluid collection after lymph nodes resection expressed in mililiters

Countries

Poland

Contacts

Primary ContactStanislaw Klek, PhD
klek@poczta.onet.pl+48604293566

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026