LYMPHA procedure to prevent arm lymphedema after axillary lymph node removal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults undergoing breast-cancer-related axillary lymphadenectomy at Stanford will receive one of three operative approaches: immediate LYMPHA lymphatic reconstruction, lymphadenectomy alone, or lymphadenectomy with soft tissue reinforcement. The study will compare rates of new-onset lymphedema using objective limb measurements alongside patient-reported quality-of-life outcomes. Eligible participants are 18–75 years old without preexisting lymphedema or distant metastases and must be able to consent and complete follow-up visits. Patients with prior axillary radiation, known allergy to porcine collagen or ICG, or recent/impending nodal radiation are excluded.

Why it matters

Who can join: the full rules

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

Where it's running

• Stanford Cancer Institute
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Dung Nguyen, MD, PharmD — Stanford University
• Study coordinator: Dung Nguyen, MD, PharmD
• Email: nguyendh@stanford.edu
• Phone: 6504929239

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.