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Prevention study for Lymphedema, Breast Cancer
Official title LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
ClinicalTrials.gov ID: NCT05366699
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.