Using Red Light Therapy to Ease Skin Side Effects and Mouth Side Effects, in Children and Young People Aged 0 to 16 Years Old, Receiving Radiotherapy

Not Applicable

Not yet recruiting

• Conditions: Radio Dermatitis; Mucositis Oral; Oesophagitis

• Registration Number: NCT07183267
• Lead Sponsor: The Christie NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-14
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Study Start: 2025-10-01
• Primary Completion: 2027-10-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 248

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, Cheshire, United Kingdom