Lymphedema, Breast CancerNCT05366699
LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
A study testing axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA), Axillary lymphadenetomy alone and axillary lymphadenectomy with soft tissue reinforcement in people with Lymphedema, Breast Cancer and Lymphedema, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lymphedema, Breast Cancer, Lymphedema
- What is being tested?
- axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA), Axillary lymphadenetomy alone and axillary lymphadenectomy with soft tissue reinforcement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2021to 1 Jun 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Cancer Institute
San Francisco, California, 94305
Dung Nguyen, PharmD, 650-498-6004, nguyendh@stanford.edu
Irene Wapnir, MD
About this study
Official title: A Randomized Clinical Trial of the LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
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
- Conditions
- Lymphedema, Breast Cancer, Lymphedema
- Being tested
- axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA), Axillary lymphadenetomy alone, axillary lymphadenectomy with soft tissue reinforcement
- Medical subject headings
- Breast Cancer Lymphedema, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)Procedure or surgery
lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins
Axillary lymphadenetomy aloneProcedure or surgery
oncologic axillary lymphadenectomy
axillary lymphadenectomy with soft tissue reinforcementProcedure or surgery
axillary lymphadenectomy with soft tissue reinforcement(STR)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Group A will under axillary lymphadenectomy alone Receives: Procedure: Axillary lymphadenetomy alone |
| Group B | Active comparator | Group B will undergo axillary lymphadenectomy with soft tissue reinforcement(STR) Receives: Procedure: axillary lymphadenectomy with soft tissue reinforcement |
| Group C | Experimental | Group B will undergo axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) using reverse mapping using the SPY System. Receives: Procedure: axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphatic flow pattern of whole limb
In the early lymphedema stages this exam allows to detect percutaneously the lymphatic vessels of the whole limb, up to about 1 cm in depth from the skin surface, by an infrared camera visualization system after intra-dermal injection of ICG in the hand. The change in the lymphatic pattern and reduction in the ICG velocity will be tested to find a correlation with other used diagnostic parameters like volume change and bioimpedance spectroscopy.
Measured: 2 yr
Limb Volume
Limb volume as measured by serial assessment
Measured: 2 yr
Skin thickness measurements
Skin thickness is changed by lymphedema
Measured: 2 yr
Bioiimpedance spectroscopy
Impedance of the skin changes with lymphedema
Measured: 2 yr
Quality of Life- Limb-Lymphedema-Specific Quality of Life (LYMQOL)
Questionnaire to determine patient reported quality of life. Measured by limb-lymphedema-specific quality of life (LYMQOL) tool. The LYMQOL is divided into four domains: Function, Appearance, Symptoms, and Mood, as well as yielding an overall quality-of-life score. Domain scores range from 0 to 4, with higher scores indicating greater impairment and worse quality of life. An additional overall quality of life score ranges from 0 to 10, with higher scores indicating better overall quality of life.
Measured: 2 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start10 Sep 2021
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema, Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dung Nguyen, MD, PharmD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366699
- Sponsor's protocol ID
- IRB-53132
- Other IDs
- NCI-2022-05172
- Status last verified
- Aug 2026
- First submitted
- 5 May 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No