NCT06144164 A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
| NCT ID | NCT06144164 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Lymphedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 285 participants |
| Start Date | 2023-11-16 |
| Primary Completion | 2030-03-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 285 participants in total. It began in 2023-11-16 with a primary completion date of 2030-03-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Michelle Coriddi, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT06144164 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Lymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06144164 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 285 participants.
Is NCT06144164 currently recruiting?
Yes, NCT06144164 is actively recruiting participants. Contact the research team at coriddim@mskcc.org for enrollment information.
Where is the NCT06144164 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT06144164 clinical trial?
NCT06144164 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Michelle Coriddi, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 285 participants.