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NCT Number: NCT04915599

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

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.

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Key information

Conditions

Oral Mucositis Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel, Radiotherapy and Radiation Oncology

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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 rate of OM up to 6 weeks after end of Treatment (EOT)

  2. 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.

    Change in degree of acute OM up to 6 weeks after EOT, using the CTCAE V5- scale (1 = mild to 5 = death)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Acronym: CooRay

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2021
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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