Innovative intraoral cooling device better tolerated and equally effective as ice cooling

Abstract

PurposeMost of the patients who receive myeloablative therapy prior to stem cell transplantation develop oral mucositis (OM). This adverse reaction manifests as oral mucosal erythema and ulcerations and may require high doses of morphine for pain alleviation. OM may also interfere with food intake and result in weight loss, a need for parenteral nutrition, and impaired quality of life. To date, there have been very few studies of evidence-based interventions for the prevention of OM. Cryotherapy, using ice chips, has been shown to reduce in an efficient manner the severity and extent of OM, although clinical applications are still limited due to several shortcomings, such as adverse tooth sensations, problems with infectious organisms in the water, nausea, and uneven cooling of the oral mucosa. The present proof-of-concept study was conducted to compare the tolerability, temperature reduction, and cooling distribution profiles of an intra-oral cooling device and ice chips in healthy volunteers who did not receive myeloablative treatment, and therefore, did not experience the symptoms of OM.MethodsTwenty healthy volunteers used the cooling device and ice chips for a maximum of 60 min each, using a cross-over design. The baseline and final temperatures were measured at eight intra-oral locations using an infra-red thermographic camera. The thermographic images were analysed using two digital software packages. A questionnaire was used to assess the tolerability levels of the two interventions.ResultsThe intra-oral cooling device was significantly better tolerated than the ice-chips (p = 0.0118). The two interventions were equally effective regarding temperature reduction and cooling distribution.ConclusionsThe intra-oral cooling device shows superior tolerability in healthy volunteers. Furthermore, this study shows that temperature reduction and cooling distribution are achieved equally well using either method.Electronic supplementary materialThe online version of this article (doi:10.1007/s00280-017-3434-2) contains supplementary material, which is available to authorized users.

Primary evaluation of an air-cooling device to reduce oral mucositis: a pilot study in healthy volunteers

“…We also demonstrated that cold air is capable of reducing the temperature in the oral mucosa by 10.9 °C after just 5 min of treatment with an average temperature of 4.0 °C. 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.…”

“…In randomized clinical trials, cooling has been achieved using ice and ice-chips for 30-60 min during chemotherapy infusions [15,17,18]. Studies have shown that OC with ice for 60 min reduces the temperature in the oral mucosa by 8.1-12.9 °C [19,20]. However, the intervention is experienced as troublesome for many of the patients.…”

“…However, the intervention is experienced as troublesome for many of the patients. Reported adverse events are teeth tingling, freezing, headache, and nausea [19,20]. For children, compliance to OC is even more problematic.…”

Protocol for a randomised controlled trial to study cryoprevention of chemotherapy-induced oral mucositis after autologous stem cell transplantation

“…To prevent OM, an intraoral cooling device (Cooral) has been developed. 7 Cooral consists of closed conduits with continuously circulating water, to cool the cheeks, lips, floor of the mouth, tongue gums and hard palate. By offering Cooral, we intend to prevent OM.…”

Cooling of the oral mucosa to prevent adverse effects of chemotherapeutic agents: An in vitro study

“…Pre‐incubation temperatures for the TEOM models were selected based on 2 separate studies on healthy volunteers where an approximate mean temperature of 25‐30°C was obtained in the oral mucosa . These temperatures were further selected with an interval of 5°C as they represented clinically relevant temperatures.…”