Abstract
Oral mucositis is a common side effect of chemo and radiotherapy causing painful ulcers in the oral mucosa. One of the preventive treatments recommended in international guidelines is oral cryotherapy (OC). Randomized clinical trials on OC have used ice and ice-chips to cool the mouth, but this cooling method can be difficult for the patients to tolerate. Studies have shown that OC with ice for a period of 60 min reduces the oral temperature by 12.9 °C. The aim of this pilot study was to evaluate the temperature reduction and tolerability of OC using an intra-oral air-cooling (IOAC) device in healthy volunteers. Twelve healthy volunteers, mean age 35.4 years, were included in the study. They were treated with OC using the IOAC device for 60 min. Measurements of temperature were obtained at baseline, 5 and 60 min using a FLIR® C2 camera. After the OC session, tolerability and adverse events were documented using a questionnaire. All participants were able to use the device for 60 min. The overall temperature reduction after 5 min of OC was 10.7°C (p < 0.01) and after 60 min 14.5°C (p < 0.01). The most common adverse events were bad fit of the mouthpiece (n = 6), hypersalivation (n = 6), and difficulties swallowing (n = 5). The oral device reduced the temperature of the oral mucosa as much as treatment with ice with tolerable adverse events. The mouthpiece will be remodeled to improve tolerability before further studies are conducted.
Highlights
Oral mucositis (OM) is a common side effect of chemo and radiotherapy in both children and adults [1,2,3]
The insulation of the tube between the cooling unit and mouthpiece was displaced resulting in higher output temperatures. This resulted in a lower temperature reduction at 60 min for these two participants compared to the rest (13.1 °C compared to 14.7 °C, p = 0.03)
These results are comparable to those of Walladbegi et al [20] and Svanberg et al [19] who demonstrated that the cooling of the oral mucosa with ice after 60 min of treatment in healthy volunteers led to a temperature reduction of 8.1 °C and 12.9 °C, respectively
Summary
Oral mucositis (OM) is a common side effect of chemo and radiotherapy in both children and adults [1,2,3]. OM is considered one of the most debilitating side effects of chemotherapy treatments according to patients, and it causes pain, nutritional difficulties and an increased risk of infections [4,5,6,7]. OM can be a dose-limiting factor leading to reduced doses and postponed treatments affecting the prognosis of the patient [1]. Among patients receiving standard chemotherapy regimens, the incidence.
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