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

Primary Purpose

Oral Mucositis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Cooral® mouth cooling device (MCD)
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Oral Mucositis focused on measuring Cooral ® Mouth cooling device (MCD), cryotherapy, radiation therapy, severe oral Mucositis, Head and Neck Cancer, Mouth Cooling Device

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Basel, Radiotherapy and Radiation Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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)

Full Information

First Posted
May 26, 2021
Last Updated
May 30, 2022
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04915599
Brief Title
Feasibility and Patient Reported Tolerance of Cryotherapy With the Cooral ® Mouth Cooling Device [MCD) in Patients Undergoing Radiation Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
April 4, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
Cooral ® Mouth cooling device (MCD), cryotherapy, radiation therapy, severe oral Mucositis, Head and Neck Cancer, Mouth Cooling Device

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm pilot trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cooral® mouth cooling device (MCD)
Intervention Description
Cooral® mouth cooling device (MCD) to prevent oral mucositis (QM) in patients undergoing radiation therapy for head and neck malignancies
Primary Outcome Measure Information:
Title
Change in Feasability Questionnaire (regarding Patient reported tolerance of cryotherapy with Cooral ®)
Description
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).
Time Frame
up to 1 week (assessed in radiotherapy treatment period (0-10 days after baseline)
Secondary Outcome Measure Information:
Title
Change in rate of OM up to 6 weeks after end of Treatment (EOT)
Description
Change in rate of OM up to 6 weeks after end of Treatment (EOT)
Time Frame
Assessed at baseline (0-10 days before RT) and once a week during RT and up to 6 weeks post RT.
Title
Change in degree of acute OM up to 6 weeks after EOT
Description
Change in degree of acute OM up to 6 weeks after EOT, using the CTCAE V5- scale (1 = mild to 5 = death)
Time Frame
Assessed at baseline (0-10 days before RT) and once a week during RT and up to 6 weeks post RT.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Bunea, MD
Organizational Affiliation
University Hospital Basel, Radiotherapy and Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel, Radiotherapy and Radiation Oncology
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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