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 (RADIANT)

The Christie NHS Foundation Trust

Status: Not yet enrolling

Conditions: Mucositis Oral; Oesophagitis; Radio Dermatitis

Treatments: Device: Photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07183267

CFTSp248

Details and patient eligibility

About

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.

Enrollment: 248 estimated patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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248 participants in 1 patient group

Photobiomodulation

Experimental group

Description:

Participants will received 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.

Treatment:

Device: Photobiomodulation