The Chemo Mouthpiece™ is currently being studied in a randomized, placebo controlled, prospective, multi-center trial. The purpose of the trial is to assess the efficacy of this cryotherapy device versus best supportive oral care in mitigating and easing the symptoms of chemotherapy related oral mucositis, a painful and debilitating condition. Click here to see trial design and information.
The Chemo Mouthpiece™ is simply an ice pack for the inside of the mouth.The device is comprised of three components: medical grade silicone, fresh water, and a proprietary saline solution. Its innovative design has 2 chambers: an inner chamber filled with fresh water and an outer chamber filled with a proprietary saline solution. When placed in a standard freezer, the inner fresh water chamber freezes solid while the chamber filled with the saline solution will not freeze solid. The frozen inner chamber allows the circulating saline solution in the outer chamber to stay very cold which cools the patient's entire oral cavity and an outer chamber filled with a proprietary saline solution.
Oral cryotherapy, in the form of ice chips, is widely used and recognized by NCCN, MASCC and ONS to prevent oral mucositis. Cryotherapy used during treatment reduces blood flow to the oral cavity by narrowing the blood vessels, a mechanism known as vasoconstriction. This limits the amount of chemotherapy drugs flowing to the oral cavity; therefore, helping to mitigate oral mucositis. The Chemo Mouthpiece™ is a more efficient option than ice as it cools the entire oral cavity uniformly, is more tolerable for patients whose teeth are sensitive, does not melt the way ice does in the patient's mouth which potentially causes the patient to feel nauseous.
The Chemo Mouthpiece, LLC has filed for numerous patents both in the US and globally. A number of patents have already been granted. The status of those not yet granted is either published or pending.