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A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People with Breast Cancer
Trial Status: active
This clinical trial tests how well a lymphedema prevention program works to reduce lymphedema after axillary lymph node dissection (ALND) surgery in women with breast cancer. Lymphedema is a condition in which extra lymph fluid builds up in tissues and causes swelling. It may occur in an arm or leg if lymph vessels are blocked, damaged, or removed by surgery like axillary lymph node dissection surgery. The lymphedema prevention program was designed to reduce lymphedema and consists of performing immediate surgery to reconstruct the lymphatic drainage of the arm (immediate lymphatic reconstruction, [ILR]) after ALND and performing activities after surgery, including lymphedema physiotherapy (lymphatic massage and range of motion exercises), physical therapy, and wearing compression garments (tight sleeves that prevent fluid buildup). Completing the lymphedema prevention program may reduce lymphedema and improve quality of life in women with breast cancer.
Inclusion Criteria
Female sex
Diagnosis of breast cancer
Aged 18 to 75 years
Consented for unilateral ALND or for unilateral sentinel lymph node biopsy (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
Additional locations may be listed on ClinicalTrials.gov for NCT06144164.
I. Determine whether a lymphedema prevention program can decrease the cumulative incidence of breast cancer-related lymphedema (BCRL) at 24 months postoperatively by use of arm volume measurements.
SECONDARY OBJECTIVES:
I. Describe and estimate the cumulative incidence of 24-month BCRL by use of bioimpedance measurements following a lymphedema prevention program.
II. Describe the lymphatic dysfunction in patients treated for breast cancer with axillary lymph node dissection (ALND) by use of indocyanine green (ICG) lymphography after a lymphedema prevention program.
III. Determine whether a lymphedema prevention program can improve quality of life in patients with BCRL by use of patient-reported outcomes measures (PROMs).
IV. Conduct two descriptive subgroup analyses, where we will summarize and describe the cumulative incidence of BCRL at 24 months using arm volume and bioimpedance, lymphatic dysfunction, and PROMs in the following: a subgroup of black women enrolled in the study and a subgroup of patients who did not undergo immediate lymphatic reconstruction (ILR) intraoperatively after ALND (not to be included in primary analysis)
OUTLINE:
Within 6 weeks prior to surgery, patients undergo an education session discussing lymphedema, and prevention of it. Patients then undergo ALND surgery with ILR and ICG lymphography during the surgery. Starting within 24 to 48 hours after surgery, patients complete lymphatic massage and range of motion exercises 3 times a week and wear a compression garment daily for at least 8 hours a day for 3 months from surgery or until 3 months after completion of treatments. Patients then receive a physical therapy referral on study. Patients also undergo ICG lymphography during follow up.
After completion of study intervention, patients are followed up at 2-6 weeks, and then at 6, 12, 18, 24, 36, 48, and 60 months after ALND.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMemorial Sloan Kettering Cancer Center
