A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
NCT ID: NCT06144164
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
285 participants
INTERVENTIONAL
2023-11-16
2030-03-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Participants with Breast Cancer
Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.
Immediate Lymphatic Reconstruction
Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection
Volumetric arm measurements
Volumetric arm measurements will occur at each in-person postoperative visit time points.
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
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
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
Interventions
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Immediate Lymphatic Reconstruction
Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection
Volumetric arm measurements
Volumetric arm measurements will occur at each in-person postoperative visit time points.
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of breast cancer
* Ages 18 to 75 years
* Consented for unilateral ALND or for unilateral SLNB with possible ALND
Exclusion Criteria
* 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
18 Years
75 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Michelle Coriddi, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Michelle Coriddi, MD
Role: primary
Michelle Coriddi, MD
Role: primary
Michelle Coriddi, MD
Role: primary
Michelle Coriddi, MD
Role: primary
Michelle Coriddi, MD
Role: primary
Michelle Coriddi, MD
Role: primary
Michelle Coriddi, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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23-303
Identifier Type: -
Identifier Source: org_study_id