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

Arms (1)

1. type

   EXPERIMENTAL

   label

   Intervention group

   description

   Patients are assigned to using the Cooral® MCD after radiotherapy for 60 min. along with general oral care (GOC). The MCD will be placed into the subjects' mouth and remain intraorally for 60 minutes. After each fraction, i.e. session of RT, the subjects insert the MCD inside their mouth and can start the Cooral ® thermostat system themselves when they feel comfortable. The stopwatch will be started by the patient as soon as thermostat is running. The patient is asked to write down the starting and the stopping time of the 60-minute procedure. Thereafter the subject will receive a questionnaire to record the tolerance for the device. Patients will be also informed about standard of care (SOC) that should be regularly performed.

   interventionNames

   1. Device: Cooral® mouth cooling device (MCD)

Primary outcomes (1)

1. measure

   Change in Feasability Questionnaire (regarding Patient reported tolerance of cryotherapy with Cooral ®)

   timeFrame

   up to 1 week (assessed in radiotherapy treatment period (0-10 days after baseline)

   description

   Change in Feasability Questionnaire (regarding Patient reported tolerance of cryotherapy with Cooral ®). On this questionnaire provided to the patients at each session, they are asked to enter the break intervals and to choose a reason for the interruption from a list or to enter another reason in a provided text field. On the form there are additional question regarding the comfort of handling and wearing the device on a four scale questionnaire (the lower the score, the better the comfort of handling and wearing the device).