Clinical trial NCT04915599: Feasibility and Patient Reported Tolerance of Cryotherapy With the Cooral ® Mouth Cooling Device [MCD) in Patients Undergoing Radiation Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Keywords: Cooral ® Mouth cooling device (MCD)
cryotherapy
radiation therapy
severe oral Mucositis
Head and Neck Cancer
Mouth Cooling Device
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pilot trial
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
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)
Secondary outcomes:
measure: Change in rate of OM up to 6 weeks after end of Treatment (EOT)
timeFrame: Assessed at baseline (0-10 days before RT) and once a week during RT and up to 6 weeks post RT.
measure: Change in degree of acute OM up to 6 weeks after EOT
timeFrame: Assessed at baseline (0-10 days before RT) and once a week during RT and up to 6 weeks post RT.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Radiotherapy and Radiation Oncology
Study officials:
affiliation: University Hospital Basel, Radiotherapy and Radiation Oncology
name: Andrei Bunea, MD
role: PRINCIPAL_INVESTIGATOR
References: