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NCT Number: NCT07183267

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

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.

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Key information

Conditions

Radio Dermatitis Digestive System Diseases Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Mouth Diseases Mucositis Oral Oesophagitis Stomatitis Stomatognathic Diseases

Age range

0 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photobiomodulation

Device

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.

Other names: Red light therapy, LED light therapy

Primary outcomes

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

    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.

    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 outcomes

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

    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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ed Smith

CONTACT

[email protected]

+44 161 446 3000

Natalie Higgins

CONTACT

[email protected]

+44 161 918 2478

Sponsors and collaborators

Lead sponsor

The Christie NHS Foundation Trust

Other

Registry information

Official study title

Reducing rAdiation aDverse Effects of dermatitIs and mucosAl inflammatioN Using Red Light Therapy

Acronym: RADIANT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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