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LYMPHA Procedure for Preventing Lymphedema After Breast Cancer Surgery

This study is looking at ways to prevent lymphedema (swelling caused by a build-up of lymph fluid) in women who are having surgery for breast cancer. Lymphedema can happen after axillary lymphadenectomy (surgery to remove lymph nodes in the armpit). Researchers want to see if a procedure called LYMPHA, which reconstructs cut lymphatic vessels, can reduce the risk of developing lymphedema. They will compare LYMPHA to axillary lymphadenectomy alone or with soft tissue reinforcement. The study will measure how lymph fluid flows, limb volume, and skin thickness over two years to see if LYMPHA is effective. You may be able to join if you are a woman between 18 and 75 years old, having surgery for breast cancer, and do not have cancer spread to other parts of your body. The study status is currently unclear.

Study design
This interventional study plans to enroll 80 participants. It compares three different surgical approaches for breast cancer.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years after their procedure to measure lymphatic flow, limb volume, and skin thickness.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05366699

LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

Recruiting
NAAges 18–75InterventionalSupportive care
Stanford University
~100 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)Axillary lymphadenetomy aloneaxillary lymphadenectomy with soft tissue reinforcement

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lymphatic flow pattern of whole limb
Measured over 2 yr
+4 more outcomes measured

Conditions

Lymphedema, Breast Cancer
Lymphedema

Explore related trials

Breast CarcinomaLymphedema

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Dung Nguyen, MD, PharmD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Dung Nguyen, MD, PharmD
[email protected]
6504929239
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Lymphatic flow pattern of whole limb2 yr

    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.

  • Limb Volume2 yr

    Limb volume as measured by serial assessment

  • Skin thickness measurements2 yr

    Skin thickness is changed by lymphedema

  • Bioiimpedance spectroscopy2 yr

    Impedance of the skin changes with lymphedema

  • Quality of Life- Limb-Lymphedema-Specific Quality of Life (LYMQOL)2 yr

    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.