Recruiting
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
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.
ClinicalTrials.gov IDNCT06144164
PhasePHASE3
Enrollment285
SponsorMemorial Sloan Kettering Cancer Center
Age18 Years
SexFEMALE
Conditions studied
Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Breast Cancer, Breast Carcinoma, Female Breast Cancer
About this study
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.
Interventions
- 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
Primary outcomes
- The difference between the baseline and postoperative arm volume measurement (Up to 24 months)
Eligibility information
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
Study 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
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.