Acebilustat for Arm Lymphedema
(HEAL Trial)
Trial Summary
What is the purpose of this trial?
This trial tests a drug called acebilustat to see if it can help people with swelling in one arm (unilateral upper extremity lymphedema). Participants will take the drug for several months. The goal is to see if acebilustat can reduce inflammation and fluid buildup in the affected arm.
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain medications. Specifically, you must stop using non-steroidal anti-inflammatory drugs (like ibuprofen), immunosuppressive drugs, leukotriene pathway inhibitors, and statin drugs. Statin drugs should be discontinued at least 2 weeks before joining the trial.
How does the drug Acebilustat differ from other treatments for arm lymphedema?
Research Team
Stanley Rockson, MD
Principal Investigator
Stanford University
Eligibility Criteria
This trial is for adults aged 18-75 with stage 2 upper arm lymphedema lasting over 6 months. Participants must have completed lymphedema therapy at least 8 weeks prior, be vaccinated against COVID-19, and use compression garments. They can't join if they have clotting disorders, chronic infections in the limb, kidney or liver disease, are pregnant/nursing, have a history of substance abuse within the last six months or are on certain medications like statins.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral placebo and acebilustat for 9 months, with 3 months on placebo and 6 months on acebilustat
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Acebilustat
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Celltaxis LLC
Collaborator