Breast Cancer Clinical Trial
Official title:
A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life
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.
Status | Recruiting |
Enrollment | 285 |
Est. completion date | March 16, 2030 |
Est. primary completion date | March 16, 2030 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey |
United States | Memorial Sloan Kettering Commack (Limited Protocol Activities) | Commack | New York |
United States | Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York |
United States | Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown | New Jersey |
United States | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey |
United States | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York |
United States | Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Up to 24 months |
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