Actively Recruiting
A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer to Evaluate a Comprehensive Prevention Program for Lymphedema and Quality of Life
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-11-10
285
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a thorough prevention program can help drain lymph fluid from the arm and prevent lymphedema in women diagnosed with breast cancer who undergo axillary lymph node dissection. The study, sponsored by Memorial Sloan Kettering Cancer Center, is a phase 3 prospective cohort study focusing on reducing lymphedema and improving quality of life after treatment for breast cancer. The program includes immediate lymphatic reconstruction performed during axillary lymph node dissection, followed by self-directed lymphatic massage and range of motion exercises starting 24 to 48 hours after surgery. Participants will also use compression garments daily for at least 8 hours a day for 3 months or until 3 months after completing any additional treatments like chemotherapy or radiation. Arm volume measurements will be taken at each in-person postoperative visit to monitor progress. Participants will be involved in regular follow-up visits for up to 24 months, during which their arm volume will be measured to assess changes from baseline. The study tracks adherence to lymphatic massage, exercises, and compression garment use. Researchers will use these assessments to evaluate the program's effect on reducing arm swelling and improving quality of life after breast cancer surgery.
CONDITIONS
Brief Title
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex
- Diagnosis of breast cancer
- Ages 18 to 75 years
- Consented for unilateral axillary lymph node dissection or for unilateral sentinel lymph node biopsy with possible axillary lymph node dissection
You will not qualify if you...
- Male sex
- Does not speak English
- Does not fit into study garment
- Axillary recurrence
- History of axillary lymph node dissection
- Requirement of bilateral axillary lymph node dissection for breast cancer treatment
- Treatment with sentinel lymph node biopsy only
- Known anaphylactic allergy to indocyanine green dye used in immediate lymphatic reconstruction
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At time of surgery and initial recovery period
Participants undergo axillary lymph node dissection with immediate lymphatic reconstruction at the time of surgery. After surgery, participants begin self-directed lymphatic massage and range of motion exercises 24 to 48 hours later, and start daily compression garment use.
1 surgical visit and initial post-operative visit
Duration - Up to 3 months or until 3 months after completion of adjuvant treatments
Participants continue lymphatic massage 3 times a week and wear compression garments daily for at least 8 hours a day for 3 months or until 3 months after any adjuvant treatments are completed. Volumetric arm measurements are taken at each in-person post-operative visit to monitor arm volume changes.
Multiple in-person post-operative visits with volumetric arm measurements
Duration - Up to 24 months
Participants are monitored for changes in arm volume and quality of life for up to 24 months after baseline.
Periodic follow-up visits for arm volume assessments
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
M
Michelle Coriddi, MD
B
Babak Mahrara, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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