Your session is about to expire
← Back to Search
Procedure
Lymphedema Prevention Program for Breast Cancer
Phase 3
Recruiting
Led By Michelle Coriddi, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female sex
Ages 18 to 75 years
Must not have
Treatment with SLNB only
Requirement of bilateral ALND for the treatment of breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests if a program can help with lymph drainage & prevent lymphedema in breast cancer patients.
Who is the study for?
This trial is for women aged 18-75 with breast cancer who are undergoing or may undergo axillary lymph node dissection (ALND). They must be able to consent and speak English. It's not open to men, those allergic to ICG dye used in one of the procedures, patients needing bilateral ALND, those treated with SLNB only, have axillary recurrence or a history of ALND, or have impaired decision-making capacity.
What is being tested?
The study tests a comprehensive prevention program that includes lymphatic massage, immediate lymphatic reconstruction surgery (ILR), volumetric arm measurements to track swelling, use of compression garments, and range-of-motion exercises. The goal is to see if these combined efforts can prevent lymphedema after breast cancer surgery.
What are the potential side effects?
Potential side effects might include discomfort from massages or exercises and skin irritation from compression garments. Surgical risks involve typical postoperative complications like infection or adverse reactions to anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am female.
Select...
I am between 18 and 75 years old.
Select...
I have agreed to undergo a specific type of lymph node removal surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have only had a sentinel lymph node biopsy.
Select...
I need both sides of my armpit lymph nodes removed for breast cancer treatment.
Select...
I am male.
Select...
I do not speak English.
Select...
I have difficulty making decisions due to my health condition.
Select...
I have had lymph nodes removed from my armpit.
Select...
My cancer has returned in the underarm area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The difference between the baseline and postoperative arm volume measurement
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with Breast CancerExperimental Treatment5 Interventions
Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
599,553 Total Patients Enrolled
9 Trials studying Lymphedema
3,867 Patients Enrolled for Lymphedema
Michelle Coriddi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
180 Total Patients Enrolled
1 Trials studying Lymphedema
180 Patients Enrolled for Lymphedema