Actively Recruiting
ILR to Prevent BRCL_MCC 23608
Led by University of South Florida · Updated on 2026-04-30
98
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the effectiveness of Immediate Lymphatic Reconstruction (ILR) in preventing breast cancer-related lymphedema (BCRL) in high-risk patients. It will also assess the safety and quality of life outcomes associated with the procedure. The main questions it aims to answer are: Does ILR reduce the incidence of BCRL in patients undergoing axillary lymph node dissection (ALND)? What are the patient-reported outcomes and quality of life differences between those who receive ILR and those who do not? Participants will be identified as high-risk for developing BCRL through a multidisciplinary tumor board and referred to a specialized clinic for further evaluation. High-risk patients will undergo a series of screening tests, including bioimpedance spectroscopy (BIS), circumferential limb measurements, and infrared 3D perometry. Participants will be randomly assigned to one of two groups: Intervention Group (Study Arm A): Undergo ILR during ALND surgery, where preserved lymphatic channels are connected to nearby veins to prevent lymphedema. Control Group (Study Arm B): Will not receive ILR, but efforts will be made to preserve lymphatic channels during surgery. Patients will be blinded to their group assignment. Post-surgery, all participants will receive education from a certified lymphatic physical therapist. At the 2-week postoperative visit, participants will be further randomized into two postoperative monitoring protocols: BCRL Clinical Pathway: Patients will have regular follow-up visits every three months for two years, including repeat BIS, limb measurements, perometry, and quality of life questionnaires (LYMQOL and ULL-27). Standard of Care: Patients will be monitored only if they experience BCRL symptoms or after two years from ALND. The study will compare the outcomes of both groups, with a focus on the incidence of BCRL and patient quality of life, and will benchmark these results against published literature on breast cancer patients.
CONDITIONS
Official Title
ILR to Prevent BRCL_MCC 23608
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female breast cancer patients aged 18 to 75 years
- Patients consenting for unilateral axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNBx) with possible ALND
- Presence of at least one transected lymphatic channel and one vein available for bypass during ALND
- Clinically or radiographically positive lymph node or high likelihood of ALND per breast surgeon
You will not qualify if you...
- Male breast cancer patients
- Non-English speaking participants
- Female breast cancer patients with axillary recurrence
- History of prior ALND
- Patients requiring bilateral ALND
- Patients treated with SLNBx only
- Primary or secondary lymphedema of the affected limb prior to surgery
- Prior axillary radiotherapy before study
- Life expectancy less than 2 years
- Pregnancy or nursing
- Substance abuse within 6 months prior to screening
- Severe psychiatric disease
- Distant metastases at preoperative screening
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
University of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
N
NIcholas Panetta, MD
CONTACT
R
Rachel A Karlnoski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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