Status:
COMPLETED
Feasibility and Patient Reported Tolerance of Cryotherapy With the Cooral ® Mouth Cooling Device [MCD) in Patients Undergoing Radiation Therapy
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Oral Mucositis
Eligibility:
All Genders
18+ years
Phase:
NA
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 n...
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 cryot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04915599
Start Date
June 22 2021
End Date
April 4 2022
Last Update
June 1 2022
Active Locations (1)
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1
University Hospital Basel, Radiotherapy and Radiation Oncology
Basel, Switzerland, 4031