Prospective, Randomized Clinical Trial for Immediate Lymphatic Reconstruction to Prevent Breast Cancer Related Lymphedema
University of South Florida
Summary
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.
Description
This study will be a randomized control trial. As part of our multidisciplinary lymphedema clinic, patients at high-risk for developing BCRL will be recruited as a part of our randomized control trial. Enrollment will last for 12 months. The clinic team consists of the plastic surgeon, certified lymphedema therapist, clinical nurse, and nutritionist. High-risk patients will be identified in breast oncology weekly multidisciplinary tumor board, consisting of surgical oncology, medical oncology, radiation oncology, and radiology, and referred to our high-risk screening clinic. High-risk patient…
Eligibility
- Age range
- 18–75 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Patients consenting for unilateral ALND \[prior history of sentinel lymph node biopsy (SLNBx) allowed if \<6 months from consent\] * Patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon * Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery * Female breast cancer patients 18-75 years of age (inclusive) Exclusion Criteria: * • Male breast cancer patients * Non-Englis…
Interventions
- ProcedureImmediate Lymphatic Reconstruction
Preserved lymphatic channels are connected to nearby veins to prevent lymphedema during the axillary lymph node dissection.
Locations (3)
- Tampa General HospitalTampa, Florida
- Moffitt Cancer CenterTampa, Florida
- University of South FloridaTampa, Florida