LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

A Randomized Clinical Trial of the LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

Lymphedema is a chronic, progressive, and debilitating condition that occurs with disruption or obstruction of the lymphatic system, which commonly occurs a result of breast cancer therapy. The purpose of this study is to determine if the use of a low risk lymphatic reconstruction procedure at the time of axillary lymph node dissection will reduce the risk of developing lymphedema.

Additionally, to determine if this procedure improves objective outcomes of lymphedema and patient quality of life

Study Overview

• Status: Recruiting
• Conditions: Lymphedema; Lymphedema, Breast Cancer
• Intervention / Treatment: Procedure: Axillary lymphadenetomy alone; Procedure: axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA); Procedure: axillary lymphadenectomy with soft tissue reinforcement

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dung Nguyen, MD, PharmD; Phone Number: 6504929239; Email: nguyendh@stanford.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94305
      • Recruiting
      • Stanford Cancer Institute
      • Contact: Dung Nguyen, PharmD; Phone Number: 650-498-6004; Email: nguyendh@stanford.edu
      • Sub-Investigator: Irene Wapnir, MD
      • Sub-Investigator: Mardi Karin, MD
      • Sub-Investigator: Frederick Dirbas, MD
      • Sub-Investigator: Jacqueline Tsai, MD
      • Sub-Investigator: Kimberly Stone, MD
      • Principal Investigator: Dung Nguyen, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ages 18 to 75 years (inclusive)
• Patients undergoing unilateral or bilateral breast cancer related axillary lymphadenectomy
• Free of distant metastasis in preoperative screening
• Histology results of axillary lymph nodes could be either Negative or Positive
• Patients who undergo preoperative chemotherapy can be included
• Willingness and ability to provide written informed consent
• Willingness and ability to comply with all study procedures

Exclusion Criteria:

• 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
• Allergic reaction to porcine collagen or ICG
• Receiving radiation therapy to the involved nodal basin in a period less than 4 weeks after the surgery
• Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening
• Other medical condition that could lead to limb edema, such as (but not limited to primary lymphedema or acute venous thrombosis
• Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (e.g., pain, swelling, decreased range of motion)
• Either of the following, at the time of baseline evaluation: ipsilateral:contralateral limb volume ratio>1.1 or R0 bioimpedance ratio > 1.106 when the nondominant limb is at risk, and 1.134 when the dominant limb is at risk.
• 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
• Significant or chronic renal insufficiency (defined as serum creatinine > 2.5 mg/dL or an estimated glomerular filtration rate [eGFR] < 30 mL/min at screening) or requires dialytic support
• Hepatic dysfunction, defined as alanine transaminase (ALT) or aspartate transaminase (AST) levels > 3 × upper limit of the normal range (ULN) and/or bilirubin level > 2 × ULN at screening
• Absolute neutrophil count < 1500 mm3 at screening
• Hemoglobin concentration < 9 g/dL at screening
• Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A; Group A will under axillary lymphadenectomy alone	Procedure: Axillary lymphadenetomy alone; oncologic axillary lymphadenectomy
Active Comparator: Group B; Group B will undergo axillary lymphadenectomy with soft tissue reinforcement(STR)	Procedure: axillary lymphadenectomy with soft tissue reinforcement; axillary lymphadenectomy with soft tissue reinforcement(STR)
Experimental: Group C; Group B will undergo axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) using reverse mapping using the SPY System.	Procedure: axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA); lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphatic flow pattern of whole limb	In the early lymphedema stages this exam allows to detect percutaneously the lymphatic vessels of the whole limb, up to about 1 cm in depth from the skin surface, by an infrared camera visualization system after intra-dermal injection of ICG in the hand. The change in the lymphatic pattern and reduction in the ICG velocity will be tested to find a correlation with other used diagnostic parameters like volume change and bioimpedance spectroscopy.	2 yr
Limb Volume	Limb volume as measured by serial assessment	2 yr
Skin thickness measurements	Skin thickness is changed by lymphedema	2 yr
Bioiimpedance spectroscopy	Impedance of the skin changes with lymphedema	2 yr
Quality of Life- Limb-Lymphedema-Specific Quality of Life (LYMQOL)	Questionnaire to determine patient reported quality of life. Measured by limb-lymphedema-specific quality of life (LYMQOL) tool. The LYMQOL is divided into four domains: Function, Appearance, Symptoms, and Mood, as well as yielding an overall quality-of-life score. Domain scores range from 0 to 4, with higher scores indicating greater impairment and worse quality of life. An additional overall quality of life score ranges from 0 to 10, with higher scores indicating better overall quality of life.	2 yr

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Dung Nguyen, MD, PharmD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Lymphatic Diseases; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Breast Cancer Lymphedema; Lymphedema
• Other Study ID Numbers: IRB-53132; NCI-2022-05172 (Other Identifier: National Cancer Institute: Clinical Trials Reporting Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No