NCT06144164PHASE3Recruiting
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
Start Date
11/16/2023
Completion Date
3/16/2030
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.
Eligibility Criteria
Age Range: 18 years to 75 years
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
Interventions
PROCEDURE
Immediate Lymphatic Reconstruction
DIAGNOSTIC_TEST
Volumetric arm measurements
OTHER
Lymphatic massage
OTHER
Range of motion exercises
OTHER
Compression garment use
Conditions
LymphedemaLymphedema ArmLymphedema of Upper ArmBreast CancerBreast CarcinomaFemale Breast Cancer
Locations
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
United States
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York 11553
United States