Recruiting

Lymphatic Reconstruction

Sponsor:

Stanford University

Code:

NCT05366699

Conditions

Lymphedema, Breast Cancer

Lymphedema

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)

Axillary lymphadenetomy alone

axillary lymphadenectomy with soft tissue reinforcement

Study Details

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

Conditions

Lymphedema, Breast Cancer

Lymphedema

Study ID

NCT05366699

Start date

Sep 10, 2021

Status verified date

Aug, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Group A

Group A will under axillary lymphadenectomy alone

active comparator: Group B

Group B will undergo axillary lymphadenectomy with soft tissue reinforcement(STR)

experimental: Group C

Group B will undergo axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) using reverse mapping using the SPY System.

Interventions

axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)

lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins

Axillary lymphadenetomy alone

oncologic axillary lymphadenectomy

axillary lymphadenectomy with soft tissue reinforcement

axillary lymphadenectomy with soft tissue reinforcement(STR)

Primary outcome measure

  • Lymphatic flow pattern of whole limb [ Time Frame: 2 yr ]
  • Limb Volume [ Time Frame: 2 yr ]
  • Skin thickness measurements [ Time Frame: 2 yr ]
  • Bioiimpedance spectroscopy [ Time Frame: 2 yr ]
  • Quality of Life- Limb-Lymphedema-Specific Quality of Life (LYMQOL) [ Time Frame: 2 yr ]

Central Contacts and Locations

Central contacts

Dung Nguyen, MD, PharmD

6504929239nguyendh@stanford.edu

Locations

Stanford Cancer Institute

Recruiting

San Francisco, California, United States, 94305

Contacts

Dung Nguyen, PharmD

650-498-6004nguyendh@stanford.edu

Principal Investigator:

Dung Nguyen, PharmD

More Information

Sponsor

Stanford University

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-08-12.