ILR to Prevent BRCL_MCC 23608

Conditions

• Breast Cancer Lymphedema

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Immediate Lymphatic Reconstruction — PROCEDURE
  Preserved lymphatic channels are connected to nearby veins to prevent lymphedema during the axillary lymph node dissection.

Study Details

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.

Key Dates

Start date

Oct 1, 2025

Status verified

Apr 2026

Primary completion

Oct 1, 2026

Completion

Oct 1, 2027

Study Design

Enrollment

98 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: ALND plus Immediate lymphatic reconstruction
  Undergo ILR during ALND surgery, where preserved lymphatic channels are connected to nearby veins to prevent lymphedema.
• No Intervention: ALND Alone
  Will not receive ILR, but efforts will be made to preserve lymphatic channels during surgery.

Primary Outcome Measure

Incidence of BCRL at 24-month post follow up visit [ Time Frame: 24 months Post ALND ]

Central Contacts

• NIcholas Panetta, MD
  8134868073
  [email protected]
• Rachel A Karlnoski
  7278584224
  [email protected]

Locations (3)

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