Feasibility and Patient Reported Tolerance of Cryotherapy With the Cooral ® Mouth Cooling Device [MCD) in Patients Undergoing Radiation Therapy (CooRay)
Oral Mucositis
About this trial
This is an interventional device feasibility trial for Oral Mucositis focused on measuring Cooral ® Mouth cooling device (MCD), cryotherapy, radiation therapy, severe oral Mucositis, Head and Neck Cancer, Mouth Cooling Device
Eligibility Criteria
Inclusion Criteria:
- Karnofsky Performance Score (KPS) >/= 60%
- life expectancy > 9 months
- histologically proven malignant disease of the head and neck region
- lntensity Modulated RadiationTherapy (IMRT) radiotherapy
- Minimal Dose to the oral mucosa >/= 30 Gy (EQD2 w. a/ß 2)
- Simultaneous use of mouthwashes is allowed if previously prescribed by the treating physician
Exclusion Criteria:
- history of Severe oral Mucositis (SOM) due to chemotherapy within the last 3 months
- previous radiotherapy in the head-neck region
- previous cryotherapy within the last 6 weeks
- Minimal doses </=30 Gy (EQD2 w. a/ß 2)
- known history of ethylene-vinyl acetate allergy
- Simultaneous use of other forms of oral cryotherapy
Sites / Locations
- University Hospital Basel, Radiotherapy and Radiation Oncology
Arms of the Study
Arm 1
Experimental
Intervention group
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.