Chemomouthpiece, a privately held medical device company that develops and commercializes supportive cancer care products, today announced the peer-reviewed results from its multi-center, randomized, controlled trial were published in Supportive Care in Cancer, the official journal of the Multinational Association of Supportive Care In Cancer (MASCC).
The study, "Multi-institutional, randomized, controlled trial to assess the efficacy and tolerability of a reusable, self-contained cryotherapy delivery device," evaluated the Chemo Mouthpiece, an FDA-cleared intraoral cryotherapy device, and demonstrated reductions in patient-reported oral pain and opioid or analgesic use during chemotherapy treatment.
Use of the Chemo Mouthpiece resulted in a 46% reduction in patient-reported oral pain symptoms compared to the control group. Additionally, there was a 68% reduction in opioid or analgesic use compared to the control group. The device showed efficacy across more than 30 chemotherapy regimens and 17 cancer types. The Chemo Mouthpiece was well-tolerated by patients, with no reported safety issues. Notably, 83% of patients indicated they would recommend the device for patients undergoing chemotherapy.
The Chemo Mouthpiece is a self-contained cryotherapy device designed to cool the entire oral cavity during and after chemotherapy infusion. By inducing vasoconstriction in the oral cavity, the device reduces the local presence of chemotherapy drugs, helping to mitigate mucosal injury. Available by prescription only, the device is reusable, pre-filled, and designed for use in both the clinic and at home when chemotherapy may still be circulating, supporting utility across short‑ and long half‑life regimens. The FDA awarded the Chemo Mouthpiece Breakthrough Device Designation in December 2021 and the device was FDA 510(k) cleared in January 2024.
