Impact of Oral Diets on Postoperative Fluid Collection (BC1)

Stanley Dudrick's Memorial Hospital

Status: Unknown

Conditions: Postoperative Complications

Treatments: Dietary Supplement: Immunonutrition; Dietary Supplement: Standard nutrition; Dietary Supplement: High-protein nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT05068882

BC1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 4 patient groups

Immunonutrition

Experimental group

Description:

Oral immunonutrition containing arginine, omega-PUFAs and antioxidants

Treatment:

Dietary Supplement: Immunonutrition

High-protein diet

Active Comparator group

Description:

Oral nutrition with high-protein content

Treatment:

Dietary Supplement: High-protein nutrition

Standard nutrition

Active Comparator group

Description:

Oral nutrition with standard ingredients

Treatment:

Dietary Supplement: Standard nutrition

No intervention

No Intervention group

Description:

No intervention