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

Oral Mucositis Clinical Trial

— CooRay  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04915599
• Other study ID #: 2021-00887; th21Bunea
• Status: Completed
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: April 4, 2022

Study information

• Verified date: May 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 4, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Device:
• Cooral® mouth cooling device (MCD)
Cooral® mouth cooling device (MCD) to prevent oral mucositis (QM) in patients undergoing radiation therapy for head and neck malignancies

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Radiotherapy and Radiation Oncology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.