Status:
RECRUITING
LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
Lead Sponsor:
Stanford University
Conditions:
Lymphedema, Breast Cancer
Lymphedema
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief 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 purpos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05366699
Start Date
September 10 2021
End Date
June 1 2030
Last Update
December 29 2025
Active Locations (1)
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1
Stanford Cancer Institute
San Francisco, California, United States, 94305