Oral MucositisCooRayNCT04915599
Feasibility and Patient Reported Tolerance of Cryotherapy With the Cooral ® Mouth Cooling Device [MCD) in Patients Undergoing Radiation Therapy
A study testing Cooral® mouth cooling device (MCD) in people with Oral Mucositis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Cooral® mouth cooling device (MCD)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Jun 2021to 4 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Radiotherapy and Radiation Oncology
Basel, 4031
About this study
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
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.
Read the 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
- Being tested
- Cooral® mouth cooling device (MCD)
- Keywords
- Cooral ® Mouth cooling device (MCD), cryotherapy, radiation therapy, severe oral Mucositis, Head and Neck Cancer, Mouth Cooling Device
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooral® mouth cooling device (MCD)Device
Cooral® mouth cooling device (MCD) to prevent oral mucositis (QM) in patients undergoing radiation therapy for head and neck malignancies
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Device: Cooral® mouth cooling device (MCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 1 week (assessed in radiotherapy treatment period (0-10 days after baseline)
Secondary outcomes (2)
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)
Measured: 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
Change in degree of acute OM up to 6 weeks after EOT, using the CTCAE V5- scale (1 = mild to 5 = death)
Measured: Assessed at baseline (0-10 days before RT) and once a week during RT and up to 6 weeks post RT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start22 Jun 2021
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pilot trial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrei Bunea, MD, Principal investigator, University Hospital Basel, Radiotherapy and Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915599
- Sponsor's protocol ID
- 2021-00887; th21Bunea
- Acronym
- CooRay
- Status last verified
- May 2022
- First submitted
- 26 May 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04915599
- Acronym / sponsor ID
- CooRay / 2021-00887; th21Bunea
- Conditions
- Oral Mucositis
- Keywords
- Cooral ® Mouth cooling device (MCD), cryotherapy, radiation therapy, severe oral Mucositis, Head and Neck Cancer, Mouth Cooling Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pilot trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Cooral® mouth cooling device (MCD)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Intervention group |
Primary outcome
Change in Feasability Questionnaire (regarding Patient reported tolerance of cryotherapy with Cooral ®)
Time frame: 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).
2 secondary outcomes
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.
Change in degree of acute OM up to 6 weeks after EOT
Time frame: Assessed at baseline (0-10 days before RT) and once a week during RT and up to 6 weeks post RT.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Bunea, MD principal investigator
University Hospital Basel, Radiotherapy and Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooral® mouth cooling device (MCD) in people with Oral Mucositis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Feasability Questionnaire (regarding Patient reported tolerance of cryotherapy with Cooral ®) (time frame: up to 1 week (assessed in radiotherapy treatment period (0-10 days after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.