Efficacy and safety of a temperature-controlled oral cryotherapy device in preventing oral mucositis among patients receiving high-risk anticancer regimens.

Abstract

12154 Background: Oral mucositis (OM) is a severe dose-limiting toxicity in cancer patients receiving intensive chemotherapy or novel antibody-drug conjugates (ADCs). Recent clinical data indicate that the incidence of OM with Sacituzumab Tirumotecan (sac-TMT) is as high as 54.1%, with approximately 11.1% of patients experiencing severe (Grade≥3) events. For Liposomal Doxorubicin, reported OM incidence is approximately 22%. Established therapies such as Docetaxel, Paclitaxel plus Carboplatin, and Sacituzumab Govitecan exhibit OM rates ranging from 10% to 30%. Severe OM frequently leads to excruciating pain, nutritional compromise, and treatment delays. This study evaluated the efficacy of a specialized oral cryotherapy (OC) device in preventing treatment-induced OM across these high-risk regimens. Methods: In this prospective trial, patients scheduled for high-risk regimens including Sacituzumab Tirumotecan, Sacituzumab Govitecan, Liposomal Doxorubicin, Docetaxel, or Taxane plus Carboplatin were enrolled. The intervention group received continuous OC using 8°C purified water, delivered via safe, non-toxic intraoral molds regulated by a temperature-controlled device. The protocol was administered 15 minutes prior to, throughout, and 30 minutes post-infusion. Primary endpoints included time to first OM onset, OM incidence, and WHO severity grading. Results: From September, 2025 to January, 2026, 116 patients were enrolled, with the most frequent user completing 13 OC sessions. The overall incidence of OM was only 6.9% (8/116), and all cases were Grade 1, with no interference with oral intake. In the Sacituzumab Tirumotecan (sac-TMT) subgroup (n = 26), the OM incidence was 11.5% (3/26)occurring at C2D1 (n = 2) and C4D8 (n = 1). Other subgroup incidences were as follows: Sacituzumab Govitecan, 50.0% (1/2) occurring at C2D1; Liposomal Doxorubicin, 4.2% (1/24) occurring at C2D1; Taxanes, 7.1% (2/28) both occurring at C2D8; and Epirubicin, 5.6% (1/18) occurring in C3D1. Notably, zero Grade ≥ 2 OM events were observed across all cohorts. No serious adverse events related to the temperature-controlled device were reported, and patient compliance with the OC protocol was high. Conclusions: Regulated oral cryotherapy using a temperature-controlled device and intraoral molds is a simple, cost-effective, and well-tolerated intervention that significantly reduces the incidence and severity of treatment-induced oral mucositis. Particularly for patients receiving high-risk ADCs such as Sacituzumab Tirumotecan, this standardized OC protocol should be considered a standard prophylactic measure to improve clinical outcomes and treatment adherence.