Chemomouthpiece, LLC, a privately held medical device company that develops and commercialises supportive cancer care products, today announced that the peer-reviewed results from its pivotal, multi-centre, randomised, 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, randomised, controlled trial to assess the efficacy and tolerability of a reusable, self-contained cryotherapy delivery device", evaluated the Chemo Mouthpiece®, an FDA 510(k) cleared intraoral cryotherapy device, and demonstrated statistically significant reductions in patient-reported oral pain and opioid or analgesic use during chemotherapy treatment.
Use of the Chemo Mouthpiece resulted in a 46 per cent reduction in patient-reported oral pain symptoms compared to the control group. Additionally, there was a 68 per cent 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 per cent of patients indicated they would recommend the device for patients undergoing chemotherapy.
"Cryotherapy is a well-established strategy for mitigating oral mucositis, but its traditional delivery using ice chips presents practical challenges for patients and care teams," said Stephen Sonis, DMD, DMSc, Senior Lecturer in Oral Medicine at the Harvard School of Dental Medicine and a member of the senior faculty at the Dana-Farber Cancer Institute and Brigham and Women's Hospital. "The data from this trial indicate that cryotherapy delivered by the Chemo Mouthpiece provided patients with an effective and well-tolerated alternative to ice that could be used throughout their treatment period, both in the clinic and at home. Chemo Mouthpiece-delivered cryotherapy reduced patients' symptoms and need to rely on analgesics for pain management."
