Clinical Trial 23608

• Overview

  Study Title:

  Prospective, Randomized Clinical Trial for Immediate Lymphatic Reconstruction to Prevent Breast Cancer Related Lymphedema - A Randomized Controlled Trial

  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.

  Objective:

  To determine the long-term efficacy of microsurgical immediate lymphatic reconstruction (ILR) in the setting of complete axillary lymph node dissection (ALND) to reduce the incidence of breast cancer related lymphedema (BCRL). To define best practices via prospective randomized study of a comprehensive screening and diagnostic BCRL Clinical Pathway for detection of preclinical/early stage BCRL and elucidate clinical variables that place patients at increased risk of procedural failure following ILR

• Inclusion Criteria

  Key Inclusion Criteria:
  • Patients consenting for unilateral ALND [prior history of sentinel lymph node biopsy (SLNBx) allowed if > 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

  Key Exclusion Criteria:
  • Male breast cancer patients
  • Non-English speaking participants
  • Female breast cancer patients with axillary recurrence
  • Female breast cancer patients who have a history of ALND
  • Female patients requiring bilateral ALND for the treatment of their breast cancer
  • Female breast patients treated with SLNBx only
  • Primary lymphedema of the affected upper limb
  • Secondary lymphedema of the affected limb prior to the lymphadenectomy
  • Radiotherapy at the axilla before the study / surgery
  • Life expectancy > Pregnancy or nursing
  • Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening
  • Severe psychiatric disease
  • Distant metastases at the time of preoperative screening

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.