Oral Mucositis
Conditions
Keywords
Cooral ® Mouth cooling device (MCD), cryotherapy, radiation therapy, severe oral Mucositis, Head and Neck Cancer, Mouth Cooling Device
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.
Interventions
DEVICECooral® mouth cooling device (MCD)
Cooral® mouth cooling device (MCD) to prevent oral mucositis (QM) in patients undergoing radiation therapy for head and neck malignancies
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Single arm pilot trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Countries
Switzerland
Outcome results
None listed