Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Breast Cancer, Breast Carcinoma, Female Breast Cancer
Conditions
Keywords
immediate lymphatic reconstruction, axillary lymph node dissection, Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Breast cancer, breast carcinoma, female breast cancer, Memorial Sloan Kettering Cancer Center, 23-303
Brief summary
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.
Interventions
PROCEDUREImmediate Lymphatic Reconstruction
Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection
DIAGNOSTIC_TESTVolumetric arm measurements
Volumetric arm measurements will occur at each in-person postoperative visit time points.
OTHERLymphatic massage
Participants 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
Participants 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
OTHERCompression garment use
Participants 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
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Female sex * Diagnosis of breast cancer * Ages 18 to 75 years * Consented for unilateral ALND or for unilateral SLNB with possible ALND
Exclusion criteria
* Male sex * Does not speak English * Does not fit into study garment * Axillary recurrence * History of ALND * Requirement of bilateral ALND for the treatment of breast cancer * Treatment with SLNB only * Known anaphylactic allergy to ICG dye used in ILR * Impaired decision-making capacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference between the baseline and postoperative arm volume measurement | Up to 24 months | 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 |
Countries
United States
Contacts
Primary ContactMichelle Coriddi, MD
Backup ContactBabak Mahrara, MD
Outcome results
None listed