Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema

Not Recruiting

Trial ID: NCT02734979


To investigate whether addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm.

Official Title

Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema

Stanford Investigator(s)

Stanley G. Rockson, MD
Stanley G. Rockson, MD

Allan and Tina Neill Professor of Lymphatic Research and Medicine

Dung Nguyen
Dung Nguyen

Clinical Professor, Surgery - Plastic & Reconstructive Surgery


Inclusion Criteria:

The subject must be a breast cancer survivor, at least three years beyond completion of
cancer therapy, free of clinical disease, and eligible for surgical intervention.

   - Ages 18 to 75 years (inclusive).

   - Swelling of 1 limb that is not completely reversed by elevation or compression

   - Stage II or greater lymphedema at screening, based on the International Society of
   Lymphology (ISL) staging system

   - Completion of a full course of complete decongestive therapy (CDT), according to ISL
   guidelines at least 8 weeks prior to screening, including use of compression garments
   for at least 8 weeks without change in regimen

   - Willingness to maintain a stable regimen of self-care, with consistent use of
   compression garments from screening through the entire study duration (through the
   safety follow-up visit). Self-bandaging, use of nighttime compression garments, and
   intermittent pneumatic compression devices are allowed, but the procedures and
   regimens must remain consistent from screening though the entire study duration.

   - Two consecutive measurements of limb volume (LV) in the affected limb taken at least 1
   day apart during the screening period must be within 10% of each other. A maximum of 3
   measurements can be taken. Affected limb volume ratio >20% (affected limb compared to
   unaffected limb); volume measurements will be performed and volume ratio will be
   calculated at S1 and S2 visit.

   - Evidence of abnormal bioimpedance ratio, if feasible based upon unilateral disease:
   L-Dex >10 units; bioimpedance performed at S1 and S1

   - Willingness and ability to understand and the willingness to sign a written informed
   consent form document

   - Willingness and ability to comply with all study procedures, including measurement of
   skin thickness using skin calipers.

   - Participants must have NED, completed breast cancer therapy 3 years prior to

   - ECOG 0- 2

Exclusion Criteria:

   - Edema arising from increased capillary filtration will be excluded.

   - 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 of (≤8 weeks), or intention to initiate, CDPT or maintenance
   physiotherapy for lymphedema at any time during the duration of the study

   - Other medical condition that could lead to acute limb edema, such as (but not limited
   to) 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)

   - History of clotting disorder (hypercoagulable state)

   - Chronic (persistent) infection in the affected limb

   - Any other infection (unrelated to lymphedema) within 1 month prior to screening

   - Current evidence of malignancy or any high risk for breast cancer recurrence (Stage
   III or IV, ER/PR/HER-2 negative (triple negative) cancer , locally advanced disease,
   inflammatory breast cancer, > 3 positive axillary lymph nodes, extracapsular nodal
   extension, invasive micropapillary breast carcinoma, or if performed, patients with a
   high risk of recurrence based on multi-gene signatures, e.g. BRCA1, BRCA 2, Oncotype
   DX (high risk recurrence score) or Mammaprint (poor risk signature)

   - Currently receiving chemotherapy or radiation therapy

   - Life expectancy < 2 years for any reason

   - Pregnancy or nursing

   - Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening

   - 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

   - Known sensitivity to porcine products

   - Any reason (in addition to those listed above) that, in the opinion of the
   investigator, precludes full participation in the study


device: Biobridge and lymph node transfer

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Leslie Roche, RN

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