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

University Hospital Basel

Status: Completed

Conditions: Oral Mucositis

Treatments: Device: Cooral® mouth cooling device (MCD)

Study type: Interventional

Funder types: Other

Identifiers

NCT04915599

2021-00887 th21Bunea;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Intervention group

Experimental 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.

Treatment:

Device: Cooral® mouth cooling device (MCD)