Breast Cancer Clinical Trial
LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
Summary
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
Eligibility Criteria
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
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There is 1 Location for this study
San Francisco California, 94305, United States More Info
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