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Feasibility and Patient Reported Tolerance of Cryotherapy With the Cooral ® Mouth Cooling Device [MCD) in Patients Undergoing Radiation Therapy — CooRay  

Oral Mucositis Clinical Trial

Official title:
Pilot Trial for Feasibility and Patient Reported Tolerance of Cryo-therapy With the Cooral ® Mouth Cooling Device [MCD) in Patients Undergoing Radiation Therapy for Head and Neck Malignancies

Clinical Trial Summary

This study is to investigate the use of the Cooral ® standardized CyT device to achieve a constant and reproducible cooling of the oral mucosa to prevent OM in patients undergoing RT in the head and neck region.

Clinical Trial Description

Severe oral mucositis (SOM) is a major side-effect during (chemo)-radiation of malignancies of the head and neck. There is no standard management of SOM. Previous studies have shown an effect of cryotherapy (CyT) on the incidence and duration of SOM in chemotherapy patients. Especially in palliative cases it is necessary to keep treatment related morbidities low. Due to the difficulties and possible side effects of ice chips (IC), a closed system, such as an intra oral mouth cooling device (MCD) might help to fully unfold the efficacy of CyT in the prevention of radiation therapy (RT)-induced oral mucositis (OM), without putting the patient at risk for infections.The Cooral ® system, provided by a Swedish medical technology company free of charge, is composed of two parts: 1) the Cooral ® system itself, which is a portable thermostat allowing to adjust temperatures , ranging between 6 and 22°C. 2) the mouthpiece composed of flexible plastic material (polyolefin polymer compound based on ethylene-vinyl acetate copolymer) that is connected via two flexible plastic hoses to the Mouth Cooling Device (MCD). The water cooled inside the thermostat then circulates through the mouthpiece, allowing the mucosa to be cooled continuously and keep the desired temperature for any time. This study is to investigate the use of the Cooral ® standardized CyT device to achieve a constant and reproducible cooling of the oral mucosa to prevent OM in patients undergoing RT in the head and neck region. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04915599
Study type Interventional
Source University Hospital, Basel, Switzerland
Contact
Status Completed
Phase N/A
Start date June 22, 2021
Completion date April 4, 2022
View Details
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