Feasibility Study of a Treatment Protocol of Pediatric Chemo- and Radiotherapy-induced Oral Mucositis by Low-level Laser Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Success of the procedure for each included child
研究概览
简要总结
Low Level Laser Therapy has been used for a few years in some pediatric hospital centers for chemo- and radiotherapy-induced oral mucositis care. It may promote ulceration's healing, limits mucositis severity and associated pain. As its use is recommended in the treatment of radio induced mucositis in adults, the level of evidence in pediatric studies does not allow a precise treatment protocol. The investigators present here the protocol of a feasibility study in the haemato-oncology department of the Children University Hospital of Toulouse, with the view to a future efficacy study.
详细描述
This study aims to evaluate the feasibility of using low level laser therapy (LLLT) in the haemato-oncology department of the Children University Hospital of Toulouse. The feasibility will be considered as acceptable if 60% of patients hospitalized for oral mucositis had successfully benefit from the procedure. The secondary objectives are the evaluation of efficacy of LLLT on pain and mucositis grade, the evaluation of tolerance of this treatment and the medical time needed for this supportive care. The athermic phototherapy laser diode will be used by scanning the entire oral mucosa area. It will be applied uniformly every two days as long as grade of mucositis is 2 or more, with a fluence of 4J/cm², under two wavelengths (635 nm and 815 nm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalization in the oncology ward of the university hospital Toulouse France
- •Onco-haematological paediatric patients treated by radio- and /or chemo-therapy, affected by an oral mucositis of WHO grade 2 to 4,
- •lack of any physical or psychological disease which could interfere with the realization of the study.
排除标准
- •Onco-haematological paediatric patients treated by radio- and /or chemo-therapy, affected by an oral mucositis of WHO's grade under 2
- •Child suffering from epilepsy
- •Patient wearing a cardiac pacemaker
- •Patient not able to open their mouth at least 20 mm
- •Patient refusing the wearing of safety goggles.
研究组 & 干预措施
intervention
Radiation : use of "Oncolase Digi" therapy laser diode
干预措施: "Oncolase Digi" therapy laser diode (Device)
结局指标
主要结局
Success of the procedure for each included child
时间窗: 7 days
The procedure is successful when low level laser has been used on all the oral mucosa minimum 3 times in the first 7 days of mucositis of grade 2. The failure of the procedure is therefore declared if the laser was applied within 3 times within 7 days.
Participation rate
时间窗: 1 year
Number of included patients related to the number of patients hospitalized for mucositis with a WHO grade of 2 or more, in one year.
次要结局
- Efficacy of low level laser therapy in the treatment of oral mucositis of grade 2(7 days)
- Pain evaluation with the Venham scale(7 days)
- Pain evaluation with the HEDEN mucositis pain scale(7 days)
- Evaluation of medical time needed for the treatment(7 days)
- Evaluation of mucositis grade(7 days)
- Evaluation of the number of laser treatment sessions(7 days)