ILR to Prevent BRCL_MCC 23608

NCT07127003 | Recruiting

• 1 other identifier: STUDY007686
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer Lymphedema

Keywords

Axillary lymph node dissection; breast cancer; lymphedema

Outcome Measures

Primary Outcomes (1)

• Incidence of BCRL at 24-month post follow up visit

  Efficacy of ILR will be measured by the incidence of BCRL at the 24 month post follow up visit

  24 months Post ALND

Study Arms (2)

ALND plus Immediate lymphatic reconstruction

EXPERIMENTAL

Undergo ILR during ALND surgery, where preserved lymphatic channels are connected to nearby veins to prevent lymphedema.

Procedure: Immediate Lymphatic Reconstruction

ALND Alone

NO INTERVENTION

Will not receive ILR, but efforts will be made to preserve lymphatic channels during surgery.

Interventions

Immediate Lymphatic Reconstruction PROCEDURE

Preserved lymphatic channels are connected to nearby veins to prevent lymphedema during the axillary lymph node dissection.

ALND plus Immediate lymphatic reconstruction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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 \< 2 years for any reason
• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (3)

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Related Publications (2)

• Gradishar WJ, Moran MS, Abraham J, Abramson V, Aft R, Agnese D, Allison KH, Anderson B, Burstein HJ, Chew H, Dang C, Elias AD, Giordano SH, Goetz MP, Goldstein LJ, Hurvitz SA, Jankowitz RC, Javid SH, Krishnamurthy J, Leitch AM, Lyons J, Mortimer J, Patel SA, Pierce LJ, Rosenberger LH, Rugo HS, Schneider B, Smith ML, Soliman H, Stringer-Reasor EM, Telli ML, Wei M, Wisinski KB, Young JS, Yeung K, Dwyer MA, Kumar R. NCCN Guidelines(R) Insights: Breast Cancer, Version 4.2023. J Natl Compr Canc Netw. 2023 Jun;21(6):594-608. doi: 10.6004/jnccn.2023.0031.

  PMID: 37308117 BACKGROUND

• Tourani SS, Taylor GI, Ashton MW. Understanding the three-dimensional anatomy of the superficial lymphatics of the limbs. Plast Reconstr Surg. 2014 Nov;134(5):1065-1074. doi: 10.1097/PRS.0000000000000640.

  PMID: 25347638 BACKGROUND

MeSH Terms

Conditions

Breast Cancer Lymphedema; Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

NIcholas Panetta, MD

CONTACT

8134868073; panetta@usf.edu

Rachel A Karlnoski

CONTACT

7278584224; karlnosk@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)