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

NCT ID: NCT04915599

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-22
• Study Completion Date: 2022-04-04

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.

Conditions

Oral Mucositis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Cooral® mouth cooling device (MCD)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrei Bunea, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Radiotherapy and Radiation Oncology

Locations

University Hospital Basel, Radiotherapy and Radiation Oncology

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2021-00887; th21Bunea

Identifier Type: -

Identifier Source: org_study_id