Clinical trial NCT05366699: LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
Official title: A Randomized Clinical Trial of the LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Lymphedema, Breast Cancer
Lymphedema
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After informed consent is obtained, all subjects will undergo an initial study evaluation to establish the pre-operative baseline and to determine eligibility for randomization. Group A will under axillary lymphadenectomy alone and Group B will undergo axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) using reverse mapping using the SPY System. Each of the baseline measures will be repeated at 3-month intervals over the 12 months of enrollment in the study. These include lymphography, limb volume measurements, skin thickness measurements, bioimpedance spectrosocpy, and quality-of-life assessment.
Primary purpose: PREVENTION

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 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

Primary outcomes:
measure: Lymphatic flow pattern of whole limb
timeFrame: 2 yr
measure: Limb Volume
timeFrame: 2 yr
measure: Skin thickness measurements
timeFrame: 2 yr
measure: Bioiimpedance spectroscopy
timeFrame: 2 yr
measure: Quality of life
timeFrame: 2 yr
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Stanford Cancer Institute
state: California
Study officials:
References: