Stanford University
Dung Nguyen
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
Lymphedema, Breast Cancer
Lymphedema
axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)
Axillary lymphadenectomy alone
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 80 participants |
Masking : | None (Open Label) |
Primary Purpose : | Prevention |
Official Title : | A Randomized Clinical Trial of the LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy |
Actual Study Start Date : | September 10, 2021 |
Estimated Primary Completion Date : | June 1, 2025 |
Estimated Study Completion Date : | June 1, 2030 |
Arm | Intervention/treatment |
---|---|
Experimental: Group A Group A will under axillary lymphadenectomy alone |
Procedure: Axillary lymphadenectomy alone |
Active Comparator: Group B Group B will undergo axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) using reverse mapping using the SPY System. |
Procedure: axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) |
Ages Eligible for Study: | 18 Years to 75 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Stanford Cancer Institute
San Francisco, California, United States, 94305