Earlier this year I posted about a clinical trial opportunity for Australians with breast cancer-related lymphedema. Pretty exciting stuff!
Even more exciting: the study has since expanded to two sites in the United States — City of Hope National Medical Center in Duarte, California, and MACRO Trials in Los Angeles — with more sites launching soon.
If you’re living with breast cancer-related lymphedema in the United States, you may be eligible to participate. The details and eligibility criteria are the same as the Aussie study, however here’s a refresher along with contact information should you wish to learn more!
The Study
The clinical trial is for an investigational new medication to treat lymphedema in patients who previously had breast cancer. The drug, LYT-100 (deupirfenidone), is an anti-inflammatory and anti-fibrotic small molecule administered in capsule form.
The study is randomized and double-blind, which means participants will be randomly assigned to receive either the drug or a placebo, and neither the participants nor the researchers know who is receiving which.
The study will run over a 48-week period and include 26 weeks of treatment. The research is ongoing in two sites in California; enrolled participants will be making regular visits to one of these study sites.
Study Criteria
Recruitment is currently open to participants in both the United States and Australia. They’re looking for men and women who:
- Are between 18-80 years old
- Are at least 6 months since breast surgery (excluding fine needle aspiration biopsy [FNA]), with no intention to have breast reconstructive surgery, nipple reconstruction, and/or tattooing during the course of the study
- Are at least 3 months since completion of treatment for breast cancer (including radiotherapy, chemotherapy, neoadjuvant, and immunotherapy) at the time of screening
- Have a diagnosis of primary breast cancer, and without evidence of recurrence of breast cancer and/or metastasis for at least 6 months since breast cancer surgery
- Have documented evidence of Stage 1 or 2 lymphedema
Visit the study site or complete this screener for full eligibility criteria.
Interested in participating?
Research studies help bring new options to patients. A few years ago I met Barbara H., a woman living with cancer-related lymphedema. At the time, she was enrolled in a clinical trial investigating a different pharmaceutical treatment for lymphedema, and we had an invigorating conversation about what participating in a research study meant to her.
“Without drug trials we can’t move forward and find help,” she had said. “So if I have to endure a few tests, that’s OK with me.”
If this resonates with you, this trial may be an opportunity for you to help others.
Check your eligibility with this quick pre-screener from Leapcure, an organization that connects patients with research trials. If you’re a good fit, the Leapcure team will get in touch with you to walk you through the next steps in the enrollment process and connect you with a nearby trial site in the United States.
Your participation could support other patients in your position and play a role in advancing research for the whole lymphedema community. Thank you for considering!
Have questions?
I am not affiliated with Leapcure nor this study. However, if you are in the United States and have any questions or would like to learn more about the study, you are welcome to call Leapcure at 800-398-0245.
More about Leapcure
Leapcure is an organization that works with over 4,500 patient advocacy groups around the world to connect patients with research trials. Their work helps further the patient voice in research and ensures access to clinical trials for patients and individuals of diverse backgrounds and communities.
The Leapcure team are excited to be part of this important research, and look forward to welcoming you!
I just had breast cancer surgery which included removing a few lymph nodes from my right arm. Not much has been said to me about the possibilities of Lymphedema aside from, “You should be fine because you are not overweight.” How proactive should I be with any type of preventive measures? Should I worry at all? Should I seek out other medical professionals who may have more information? Do I need to wear any type of medical bracelet to prevent accidental medical damage? My lifestyle was not asked about. I use my arm a lot while sailing and wear a snug wetsuit. Would this matter? What about diving, or anything else? My skin already overreacts to bites and stings. Do I need to worry about that too? Thank you for your wonderful blog.