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

N/ANot Yet RecruitingNCT07183267

The Christie NHS Foundation Trust248 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

248

Conditions

Radio Dermatitis Mucositis Oral Oesophagitis

Eligibility

Sex: ALLMin age: 0 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Paediatric Participants with Treatment-Related Skin Toxicity as Assessed by RTOG

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.

Time frame: The participant will be assessed from day one until the end of their proton or photon radiotherapy treatment course, up to 8 weeks.

Secondary Outcomes

Number of Head and Neck Participants with Treatment-Related Mucositis as Assessed by CTCAE v4.0

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.