Actively Recruiting
LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
Led by Stanford University · Updated on 2025-12-29
80
Participants Needed
1
Research Sites
455 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford Cancer Institute
San Francisco, California, United States, 94305
Actively Recruiting
Research Team
D
Dung Nguyen, MD, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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