A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 3

Conditions: Lymphedema Arm; Breast Cancer; Lymphedema of Upper Arm; Lymphedema; Female Breast Cancer; Breast Carcinoma

Treatments: Other: Range of motion exercises; Other: Compression garment use; Other: Lymphatic massage; Diagnostic Test: Volumetric arm measurements; Procedure: Immediate Lymphatic Reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT06144164

23-303

Details and patient eligibility

About

The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.

Enrollment: 285 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female sex
• Diagnosis of breast cancer
• Ages 18 to 75 years
• Consented for unilateral ALND or for unilateral SLNB with possible ALND

Exclusion criteria

• Male sex
• Does not speak English
• Does not fit into study garment
• Axillary recurrence
• History of ALND
• Requirement of bilateral ALND for the treatment of breast cancer
• Treatment with SLNB only
• Known anaphylactic allergy to ICG dye used in ILR
• Impaired decision-making capacity

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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285 participants in 1 patient group

Participants with Breast Cancer

Experimental group

Description:

Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.

Treatment:

Diagnostic Test: Volumetric arm measurements

Procedure: Immediate Lymphatic Reconstruction

Other: Compression garment use

Other: Lymphatic massage

Other: Range of motion exercises