Recruiting

Immediate Lymphatic Reconstruction

Sponsor:

University of South Florida

Code:

NCT07127003

Conditions

Breast Cancer Lymphedema

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Immediate Lymphatic Reconstruction

Study Details

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

Study ID

NCT07127003

Start date

Oct 1, 2025

Status verified date

Apr, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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-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

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Immediate Lymphatic Reconstruction

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

NIcholas Panetta, MD

8134868073panetta@usf.edu

Rachel A Karlnoski

7278584224karlnosk@usf.edu

Locations

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Rachel A Karlnoski, PhD

727-858-4224c-rkarlnoski@tgh.org

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Rachel Karlnoski, PhD

karlnosk@usf.edu

Principal Investigator:

Nicholas Panetta, MD

More Information

Sponsor

University of South Florida

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • Axillary lymph node dissection
  • breast cancer
  • lymphedema

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-04-30.