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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Feasability Questionnaire (regarding Patient reported tolerance of cryotherapy with Cooral ®)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Feasability Questionnaire (regarding Patient reported tolerance of cryotherapy with Cooral ®)
时间窗: 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).
次要结局
- 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 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.)