New procedure may stop debilitating arm swelling after breast cancer surgery
NCT ID NCT05366699
First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times
Summary
This study tests a low-risk surgical procedure called LYMPHA, done at the same time as breast cancer lymph node removal, to prevent lymphedema—a chronic, painful arm swelling. About 80 women undergoing breast cancer surgery will be randomly assigned to receive LYMPHA or standard care. Researchers will measure arm volume, skin changes, and quality of life to see if the procedure reduces swelling risk.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2021
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford Cancer Institute
RECRUITINGSan Francisco, California, 94305, United States
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