Status:
RECRUITING
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Lymphedema
Lymphedema Arm
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief 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
Inclusion
- Female sex
- Diagnosis of breast cancer
- Ages 18 to 75 years
- Consented for unilateral ALND or for unilateral SLNB with possible ALND
Exclusion
- 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
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 16 2030
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT06144164
Start Date
November 16 2023
End Date
March 16 2030
Last Update
November 7 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725