Program to prevent lymphedema after breast cancer surgery
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
This study is testing a prevention program to help women who have breast cancer surgery avoid lymphedema by using treatments like lymphatic massage and special garments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 285 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06144164 on ClinicalTrials.gov |
What this trial studies
This study tests a comprehensive prevention program aimed at reducing the risk of lymphedema in women undergoing axillary lymph node dissection due to breast cancer. Participants will receive immediate lymphatic reconstruction, volumetric arm measurements, lymphatic massage, range of motion exercises, and compression garment use. The goal is to facilitate lymph fluid drainage and prevent the development of lymphedema. The study is designed for women aged 18 to 75 who have been diagnosed with breast cancer and consented to the surgical procedure.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 75 diagnosed with breast cancer who are undergoing unilateral axillary lymph node dissection.
Not a fit: Patients who have a history of axillary lymph node dissection or require bilateral axillary lymph node dissection may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the incidence of lymphedema in breast cancer patients, improving their quality of life.
How similar studies have performed: Other studies have shown promise in similar approaches to lymphedema prevention, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Michelle Coriddi, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Michelle Coriddi, MD
- Email: coriddim@mskcc.org
- Phone: 646-608-8042
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.