LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorStanford University
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)
- Axillary lymphadenetomy alone
- axillary lymphadenectomy with soft tissue reinforcement
Treatment groups
80 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov