Preventing Lymphedema After Breast Cancer Surgery

This study is testing a comprehensive program to help prevent lymphedema (swelling caused by fluid buildup) in the arm after surgery for breast cancer. The program includes Immediate Lymphatic Reconstruction (a surgical procedure), self-directed lymphatic massage, range of motion exercises, and wearing a compression garment. Researchers want to see if these interventions can help lymph fluid drain properly and reduce the risk of lymphedema. You may be able to join if you are a woman between 18 and 75 years old with breast cancer who will have axillary lymph node dissection (ALND) surgery. The study will measure arm swelling for up to 24 months to see how well the program works. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 285 women. It is designed to test a comprehensive program to prevent lymphedema.
What's involved
You would undergo Immediate Lymphatic Reconstruction during your ALND surgery. You would also perform self-directed lymphatic massage and range of motion exercises three times a week, and wear a compression garment daily for at least 8 hours, for three months after surgery or until three months after any additional treatments.
Compensation
Not stated in the trial record.
Follow-up
Your arm volume will be measured at each in-person postoperative visit for up to 24 months after surgery.

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NCT06144164

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

Recruiting
PHASE3Ages 18–75InterventionalPrevention
Memorial Sloan Kettering Cancer Center
~285 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Immediate Lymphatic ReconstructionVolumetric arm measurementsLymphatic massageRange of motion exercisesCompression garment use

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The difference between the baseline and postoperative arm volume measurement
Measured over Up to 24 months
Lymphedema
Lymphedema Arm
Lymphedema of Upper Arm
Breast Cancer
Breast Carcinoma
Female Breast Cancer
7 sites across 2 states
New York4
New Jersey3
  • Michelle Coriddi, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

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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
  • The difference between the baseline and postoperative arm volume measurementUp to 24 months

    The primary objective is to determine the efficacy of a prevention program in decreasing the development of lymphedema in participants treated for breast cancer with Axillary Lymph Node Dissection/ALND by use of arm volume measurements. A ≥ 10% increase in RVC (arm volume difference between the affected and unaffected arms) between baseline and postoperative measures occurring at 12 months or later will indicate the development of lymphedema