LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

NCT05366699 | Recruiting DMC

• 3 other identifiers: IRB-53132NCI-2022-05172BRS0127
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphedema; Lymphedema, Breast Cancer

Outcome Measures

Primary Outcomes (5)

• 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

  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

  2 yr

Study Arms (3)

Group A

OTHER

Group A will under axillary lymphadenectomy alone

Procedure: Axillary lymphadenetomy alone

Group B

ACTIVE COMPARATOR

Group B will undergo axillary lymphadenectomy with soft tissue reinforcement(STR)

Procedure: axillary lymphadenectomy with soft tissue reinforcement

Group C

EXPERIMENTAL

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)

Interventions

Axillary lymphadenetomy alone PROCEDURE

oncologic axillary lymphadenectomy

Group A

axillary lymphadenectomy with soft tissue reinforcement PROCEDURE

axillary lymphadenectomy with soft tissue reinforcement(STR)

Group B

axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) PROCEDURE

lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins

Group C

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Cancer Institute

San Francisco, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dung Nguyen, MD, PharmD

CONTACT

6504929239; nguyendh@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After informed consent is obtained, all subjects will undergo an initial study evaluation to establish the pre-operative baseline and to determine eligibility for randomization. Group A will under axillary lymphadenectomy alone, Group B will undergo lymphadenectomy with soft tissue reinforcement(STR), and Group C will undergo axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) using reverse mapping using the SPY System. Each of the baseline measures will be repeated at 3-month intervals over the 12 months of enrollment in the study. These include lymphography, limb volume measurements, skin thickness measurements, bioimpedance spectrosocpy, and quality-of-life assessment.

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 9, 2022
• Study Start: September 10, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2030
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)