← 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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

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
1,972 Previous Clinical Trials
597,443 Total Patients Enrolled
Michelle Coriddi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
180 Total Patients Enrolled
~190 spots leftby Mar 2030
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top