Mucositis Oral, Oesophagitis, Radio Dermatitis
Conditions
Keywords
Paediatric skin toxicity, paediatric oral mucositis, paediatric proton therapy, paediatric radiotherapy, paediatric photon therapy
Brief summary
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: 1. Does the use of red light therapy help the skin side effects in children and young people undergoing proton or photon therapy? 2. 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.
Interventions
DEVICEPhotobiomodulation
Participants will receive a daily treatment of photobiomodulation via a LED photobiomodulation device alongside their proton or photon treatment fraction. The photobiomodulation will be administered to the skin in the site of the patients proton or photon therapy treatment area.
Sponsors
The Christie NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Paediatric patient receiving a treatment course of either proton or photon therapy - Craniospinal treatment field, Head and Neck treatment fields and body treatment fields.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Paediatric Participants with Treatment-Related Skin Toxicity as Assessed by RTOG | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | CTCAE mucositis scoring scale: Grade 0: No mucositis. Grade 1: Asymptomatic or mild symptoms; intervention not indicated. Grade 2: Moderate pain or ulcer that does not interfere with oral intake; modified diet indicated. Grade 3: Severe pain; interfering with oral intake. Grade 4: Life-threatening consequences; urgent intervention indicated. |
Countries
United Kingdom
Contacts
CONTACTNatalie Higgins
CONTACTEd Smith
STUDY_DIRECTOREd Smith
The Christie NHS Foundation Trust
Outcome results
None listed