Surgical Evaluation for Breast Cancer-Associated Lymphedema
This study, called LymphBridge, is looking at ways to improve surgical treatment for lymphedema (swelling caused by fluid buildup) in the arm after breast cancer. Researchers are investigating if adding the BioBridge® Collagen Matrix device to a standard surgery called Vascularized Lymph Node Transfer (VLNT) helps reduce arm swelling. You may be able to join if you are a breast cancer survivor, at least 3 years past your cancer treatment, free of cancer, and can safely have surgery. The main goal is to see how much the excess arm swelling changes 12 months after surgery. The study aims to enroll 60 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 60 participants.
- What's involved
- Participants will undergo a surgical procedure (Vascularized Lymph Node Transfer) and have their arm volume measured at the start and 12 months after treatment. Quality of life and lymphatic function will also be assessed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 12 months after treatment to measure changes in arm volume.
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NCT04606030
LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)
Recruiting
NAAges 18–75InterventionalTreatmentFibralign Corporation
~60 participants
Updated 2025-03-11 on ClinicalTrials.gov
What's tested:BioBridge® Collagen MatrixVascularized Lymph Node Transfer (VLNT)
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Excess limb volume change
Measured over Baseline and 12 months after treatment
Conditions
Where it's being run
2 sites across 2 statesIllinois1
Texas1
Study leadership
- David W Chang, MD, FACS · PRINCIPAL_INVESTIGATOR · The University of Chicago Medicine & Biological Sciences
- Rebecca Garza, MD · STUDY_DIRECTOR · The University of Chicago Medicine & Biological Sciences
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Ages 18 to 75 years (inclusive)
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
Life expectancy \> 2 years
Acquired (secondary) upper limb lymphedema secondary to breast cancer treatment
The participant must be eligible for surgical intervention
Swelling of 1 limb that is not completely reversed by elevation or compression
Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
Participants must have no evidence of disease (NED), have completed breast cancer therapy 3 years prior to enrollment; use of endocrine therapy is allowed.
Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen
Willingness to comply with recommended regimen of self care, with consistent use of compression garments from screening through the entire study duration (through the safety follow up visit), excluding the first 3 weeks postoperatively where patients are required to not wear compression. Self bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens are expected to remain consistent from screening though the entire study duration.
Consistent use of an appropriately sized compression garment for daytime use.
Limb volume (LV) in the affected limb and unaffected limb must be at least 10% of each other.
Evidence of abnormal bioimpedance ratio, if feasible, based upon unilateral disease: L Dex \> 10 units.
Willingness and ability to comply with all study procedures, including measurement of skin biopsy, and preoperative and postoperative imaging studies.
Willingness and ability to understand, and to sign a written informed consent form document
Exclusion
Edema arising from increased capillary filtration will be excluded (venous incompetence).
Inability to safely undergo general anesthesia and/or perioperative care related to vascularized lymph node transfer
Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening or 5 times the drug's half life, whichever is longer
Recent initiation (≤ 12 weeks) of CDPT for lymphedema
Other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure
Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (eg, pain, swelling, decreased range of motion)
History of clotting disorder (hypercoagulable state)
Chronic (persistent) infection in the affected limb
Infection of the lymphedema limb within 1 month prior to screening
Currently receiving chemotherapy or radiation therapy
Current evidence, or a history of malignancy within the past 3 years (except for non melanoma skin cancer or cervical cancer in situ treated with curative intent). If the participant has undergone cancer treatment, this must have been completed \> 3 years prior to enrollment.
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
Body Mass Index (BMI) \>35
Known sensitivity to porcine products
Anaphylaxis to iodine
Pregnancy or nursing
Substance abuse (such as alcohol or drug abuse) within 6 months prior to 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
- Excess limb volume changeBaseline and 12 months after treatment
Change in % of (excess) limb volume in the intervention group relative to control group