NCT06144164

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

A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 285 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lymphedema
• Lymphedema Arm
• Lymphedema of Upper Arm
• Breast Cancer
• Breast Carcinoma
• Female Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Immediate Lymphatic Reconstruction	Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection
DIAGNOSTIC_TEST	Volumetric arm measurements	Volumetric arm measurements will occur at each in-person postoperative visit time points.
OTHER	Lymphatic massage	Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed
OTHER	Range of motion exercises	Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed
OTHER	Compression garment use	Participants will use compression garments 24 to 48 h after surgery and will continue daily use for at least 8 h a day for 3 months or until 3 months after any adjuvant treatments are completed

Timeline

• Start date: 2023-11-16
• Primary completion: 2030-03-16
• Completion: 2030-03-16
• First posted: 2023-11-22
• Last updated: 2025-11-10

Locations

7 sites across 1 country: United States