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

Not Applicable

Completed

• Conditions: Oral Mucositis
• Interventions: Device: Cooral® mouth cooling device (MCD)

• Registration Number: NCT04915599
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-31
• Study First Posted: 2021-06-07
• Study Start: 2021-06-22
• Primary Completion: 2022-04-04
• Study Completion: 2022-04-04
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Cooral® mouth cooling device (MCD)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in degree of acute OM up to 6 weeks after 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, using the CTCAE V5- scale (1 = mild to 5 = death)
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 rate of OM up to 6 weeks after end of Treatment (EOT)

Trial Locations

Locations (1)

University Hospital Basel, Radiotherapy and Radiation Oncology; 🇨🇭 Basel, Switzerland