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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Oral Mucositis

Intervention / Treatment
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* Device: Cooral® mouth cooling device (MCD)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm pilot trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Device: Cooral® mouth cooling device (MCD)<br>* Cooral® mouth cooling device (MCD) to prevent oral mucositis (QM) in patients undergoing radiation therapy for head and neck malignancies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Feasability Questionnaire (regarding Patient reported tolerance of cryotherapy with Cooral ®) | 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). | up to 1 week (assessed in radiotherapy treatment period (0-10 days after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in rate of OM up to 6 weeks after end of Treatment (EOT) | Change in rate of OM up to 6 weeks after end of Treatment (EOT) | Assessed at baseline (0-10 days before RT) and once a week during RT and up to 6 weeks post RT. | 
| Change in degree of acute OM up to 6 weeks after EOT | Change in degree of acute OM up to 6 weeks after EOT, using the CTCAE V5- scale (1 = mild to 5 = death) | Assessed at baseline (0-10 days before RT) and once a week during RT and up to 6 weeks post RT. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cooral ® Mouth cooling device (MCD), cryotherapy, radiation therapy, severe oral Mucositis, Head and Neck Cancer, Mouth Cooling Device