LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
A Randomized Clinical Trial of the LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether the LYMPHA procedure can prevent lymphedema, or long-term swelling caused by blocked fluid flow. It is for adults having lymph nodes removed from one or both armpits because of breast cancer. The procedure repairs fluid pathways during surgery, and the study checks swelling and quality of life.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 to 75 years old.
- You are having lymph nodes removed from one or both armpits because of breast cancer.
- Tests before surgery show that cancer has not spread to distant parts of your body.
- Your armpit lymph nodes may or may not contain cancer.
- You may have had chemotherapy before surgery.
- You are willing and able to sign a written consent form.
- You are willing and able to follow all study steps.
Who can't join
- You already have lymphedema in the affected arm, or another condition that could cause arm swelling, pain, or limited movement. Certain arm size or fluid test results can also rule you out.
- You had radiation to the armpit before the study or surgery, or will receive radiation to that lymph node area less than 4 weeks after surgery.
- You are allergic to pig-derived collagen or ICG, a dye.
- You took part in another trial of an experimental drug or treatment within 1 month before screening.
- You are pregnant or nursing, have a severe mental illness, or had alcohol or drug abuse within 6 months before screening.
- You have serious or long-term kidney problems, need dialysis to filter your blood, or have liver blood tests above the study's limits.
- Your neutrophil count, a type of infection-fighting white blood cell, is below 1,500/mm³, or your hemoglobin, the blood protein that carries oxygen, is below 9 g/dL.
- Your expected lifespan is less than 2 years, or the study doctor believes another reason would keep you from fully taking part.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
CA
- Stanford Cancer Institute · San Francisco, CA 94305Dung Nguyen, PharmD · Study contact · 650-498-6004 · nguyendh@stanford.eduIrene Wapnir, MD · Sub-investigatorMardi Karin, MD · Sub-investigatorFrederick Dirbas, MD · Sub-investigatorMore trials in San Francisco