LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
NCT ID: NCT05366699
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2021-09-10
2030-06-01
Brief Summary
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Additionally, to determine if this procedure improves objective outcomes of lymphedema and patient quality of life
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A
Group A will under axillary lymphadenectomy alone
Axillary lymphadenetomy alone
oncologic axillary lymphadenectomy
Group B
Group B will undergo axillary lymphadenectomy with soft tissue reinforcement(STR)
axillary lymphadenectomy with soft tissue reinforcement
axillary lymphadenectomy with soft tissue reinforcement(STR)
Group C
Group B will undergo axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) using reverse mapping using the SPY System.
axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)
lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins
Interventions
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axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)
lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins
Axillary lymphadenetomy alone
oncologic axillary lymphadenectomy
axillary lymphadenectomy with soft tissue reinforcement
axillary lymphadenectomy with soft tissue reinforcement(STR)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
FEMALE
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Locations
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Stanford Cancer Institute
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Dung Nguyen, PharmD
Role: primary
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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NCI-2022-05172
Identifier Type: OTHER
Identifier Source: secondary_id
BRS0127
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-53132
Identifier Type: -
Identifier Source: org_study_id