About this trial
The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female sex
Diagnosis of breast cancer
Ages 18 to 75 years
Consented for unilateral ALND or for unilateral SLNB with possible ALND
Disqualifiers
Male sex
Does not speak English
Does not fit into study garment
Axillary recurrence
Trial design
Single group
Treatments tested in this trial
Immediate Lymphatic Reconstruction
Procedure/SurgeryImmediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection
Volumetric arm measurements
Diagnostic testVolumetric arm measurements will occur at each in-person postoperative visit time points.
Lymphatic massage
Other interventionParticipants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed
Range of motion exercises
Other interventionParticipants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed
Compression garment use
Other interventionParticipants will use compression garments 24 to 48 h after surgery and will continue daily use for at least 8 h a day for 3 months or until 3 months after any adjuvant treatments are completed
Treatment groups
Trial outcomes
Primary outcomes
The difference between the baseline and postoperative arm volume measurement
The primary objective is to determine the efficacy of a prevention program in decreasing the development of lymphedema in participants treated for breast cancer with Axillary Lymph Node Dissection/ALND by use of arm volume measurements. A ≥ 10% increase in RVC (arm volume difference between the affected and unaffected arms) between baseline and postoperative measures occurring at 12 months or later will indicate the development of lymphedema
Sponsors and contacts
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