What this study is
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.
What's being tested
- Immediate Lymphatic Reconstruction
Intervention · PROCEDURE
Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection
- Volumetric arm measurements
Intervention · DIAGNOSTIC TEST
Volumetric arm measurements will occur at each in-person postoperative visit time points.
- Lymphatic massage
Intervention · OTHER
- Range of motion exercises
Intervention · OTHER
- Compression garment use
Intervention · OTHER
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
Both Lymphatic massage and Range of motion exercises
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
Study details
- 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
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Lymphedema · Lymphedema Arm · Lymphedema of Upper Arm · Breast Cancer · Breast Carcinoma · Female Breast Cancer
- Enrolling
- 285 people
- Starts
- 2023-11-16
- Est. completion
- 2030-03-16
- Design
- Open-label, single group, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Female sex
- Diagnosis of breast cancer
- Ages 18 to 75 years
- Consented for unilateral ALND or for unilateral SLNB with possible ALND
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (7)
7 openContact for every open site
- Michelle Coriddi, MD · Contact646-608-8042
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
RecruitingMemorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
RecruitingMemorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
RecruitingMemorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States
RecruitingMemorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
RecruitingMemorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
RecruitingMemorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Recruiting
Study team
Sponsor
Memorial Sloan Kettering Cancer Center
Study ID 23-303
Principal investigator
Michelle Coriddi, MD
Memorial Sloan Kettering Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.