Primary evaluation of an air-cooling device to reduce oral mucositis: a pilot study in healthy volunteers
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ORIGINAL PAPER
Primary evaluation of an air‑cooling device to reduce oral mucositis: a pilot study in healthy volunteers C. Blacker1 · T. Kamsvåg1 · R. S. Bejhed1 · G. Ljungman1 Received: 30 June 2020 / Accepted: 17 October 2020 © The Author(s) 2020
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. Keywords Oral mucositis · Oral cryotherapy · Intra-oral air-cooling device · Innovative medical technology
Introduction Oral mucositis (OM) is a common side effect of chemo and radiotherapy in both children and adults [1–3]. 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 [4–7]. OM can be a dose-limiting factor leading to reduced doses and postponed treatments thus affecting the prognosis of the patient [1]. Among patients receiving standard chemotherapy regimens, the incidence C. Blacker and T. Kamsvåg have contributed equally to this work. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12032-020-01431-4) contains supplementary material, which is available to authorized users. * C. Blacker [email protected] 1
Department of Women’s and Children’s Health, Uppsala University, Entrance 95, SE‑751 85 Uppsala, Sweden
of OM is around 40%; for patients receiving radiotherapy to the head and neck, the incidence is close to 100%; and in patients undergoing hematopoietic stem cell transplantations, the incidence is around 80% [1, 8]. The risk of developing OM varies depending on the treatment regimen and doses as we
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