3 – 5 OTH is known to reduce quality of life, and no established strategies exist to prevent this toxicity. A randomized trial by Nangia et al 6 showed that the application of a “cold cap” during chemotherapy infusion reduced alopecia up to 50% in patients with breast cancer.Ĥ Recently, it has been shown that cooling of anatomic areas during chemotherapy infusion can reduce toxicity to those regions, presumably because of local vasoconstriction. In another trial by Hanai et al, 7 the application of a limb-cooling device to one hand during paclitaxel infusion reduced the development of peripheral neuropathy (PN) compared with the untreated hand. In addition, several clinical trials have shown that oral cryotherapy reduces mucositis in patients with cancer receiving 5-fluorouracil–based chemotherapy or high-dose melphalan before hematopoietic stem cell transplant. #Spss version 25 citation in jama trial#Ĩ – 10 We therefore hypothesized that oral cryotherapy delivered during oxaliplatin infusion would reduce the intensity and duration of OTH by limiting chemotherapy delivery to the oral mucosa.Ī single-institution, randomized, controlled trial was conducted to evaluate the efficacy of oral cryotherapy during oxaliplatin infusion as a preventive measure against OTH.