The Chemo Mouthpiece Clinical Trial
The Chemo Mouthpiece Clinical Research Trial
Chemo Mouthpiece LLC. has engaged world renowned Oral Mucositis expert, Dr. Steve Sonis (currently with Harvard, Dana-Farber Cancer Institute and Brigham & Women’s Hospital), to lead our clinical research trial. This trial is assessing the efficacy and utility of our novel oral cryotherapy delivery device, the Chemo Mouthpiece™ (CMP™). Specifically, we are assessing the ability of the CMP™ to mitigate symptoms associated with chemotherapy-induced oral mucositis in cancer patients being treated with standard mucotoxic chemotherapy regimens for many varied tumor types. This is a post-marketing, randomized, prospective, multi-site trial conducted within the United States. Ten top cancer institutes have been enlisted to participate in this clinical trial; these sites are located in California, Indiana, Missouri, Manhattan as well as New York State, Ohio, South Carolina, and Michigan. The trial commenced in August 2020 with a planned accrual of 200 patients. These patients are randomized to either the Chemo Mouthpiece™ Arm or the Best Supportive Oral Care Arm.
The full list of participating sites as well as a synopsis of the clinical trial can be found at: https://clinicaltrials.gov/