Effectiveness of A Reusable, Self-Contained Cryotherapy Delivery Device on Mitigating the Use and Intensity of Analgesics in Patients Being Treated with Cycled Cancer Chemotherapy: Results of A Multi-Institutional, Randomized, Controlled Trial

Oral mucositis (OM) is a painful complication in patients undergoing cytotoxic chemotherapy (CT) which impacts patients' quality of life and threatens treatment tolerance.Cryotherapy using ice chips has been effective in allaying OM symptoms in short half-life agents but has posed challenges associated with patient compliance and logistics.This study evaluated the efficacy of a reusable, self-administered cryotherapy device in mitigating analgesic use among patients receiving stomatotoxic chemotherapy (SCT).This was a multi-institutional trial in which patients planned to receive at least two cycles of SCT were randomized into two arms (2:1): best supportive care (BSC) with the cryotherapy device or BSC alone.Device use was initiated during chemotherapy infusion and continued at home for five days post-infusion.Daily diaries recorded all forms of analgesic use that were attributable to oral pain.Statistical analysis compared analgesic use between the two groups across two chemotherapy cycles.Device use significantly reduced the necessity for all forms of analgesic use, including opioids, non-opioids and rescue medications.Patients in the device arm reported fewer days of analgesic use compared to controls, with the reduction being more pronounced in the second cycle.