Reducing rAdiation aDverse Effects of dermatitIs and mucosAl inflammatioN Using Red Light Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Number of Paediatric Participants with Treatment-Related Skin Toxicity as Assessed by RTOG
研究概览
简要总结
The goal of this interventional study is to see if the daily use of red light therapy called photobiomodulation can help sore skin and sore mouths in children having radiotherapy.
All children aged 0-16 years old who are receiving either proton or photon radiotherapy treatment, except to the brain only, will be asked if they would like to join the study.
The main questions it aims to answer are:
- Does the use of red light therapy help the skin side effects in children and young people undergoing proton or photon therapy?
- Does the use of red light therapy help the mouth side effects in children and young people undergoing proton or photon therapy in the head and neck area?
Researchers will compare the patients enrolled on to the study with a like for like historic patient to see if red light therapy improves the sore skin and sore mouths caused by proton or photon therapy.
Participants will have a daily treatment with red light therapy alongside their daily proton or photon treatment fraction.
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
- 0 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paediatric patient receiving a treatment course of either proton or photon therapy - Craniospinal treatment field, Head and Neck treatment fields and body treatment fields.
排除标准
- •Paediatric patients receiving focal brain only proton or photon radiotherapy.
- •Paediatric patients receiving a single fraction of proton or photon therapy.
- •Total Body Irradiation patients.
结局指标
主要结局
Number of Paediatric Participants with Treatment-Related Skin Toxicity as Assessed by RTOG
时间窗: The participant will be assessed from day one until the end of their proton or photon radiotherapy treatment course, up to 8 weeks.
RTOG Skin Toxicity score range: Grade 0: no change Grade 1: dull erythema, decreased sweating Grade 2: moderate oedema, bright erythema, pitting oedema Grade 3: confluent moist desquamation, pitting oedema Grade 4: Ulceration, haemorrhage and necrosis.
次要结局
- Number of Head and Neck Participants with Treatment-Related Mucositis as Assessed by CTCAE v4.0(The participant will be assessed from day one until the end of their proton or photon radiotherapy treatment course, up to 8 weeks.)