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

NCT07183267 | Not Yet Recruiting DMC

• 1 other identifier: CFTSp248
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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. 1.Does the use of red light therapy help the skin side effects in children and young people undergoing proton or photon therapy?
2. 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?

Conditions

Radio Dermatitis; Mucositis Oral; Oesophagitis

Keywords

Paediatric skin toxicity; paediatric oral mucositis; paediatric proton therapy; paediatric radiotherapy; paediatric photon therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (1)

• 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.

Study Arms (1)

Photobiomodulation

EXPERIMENTAL

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.

Device: Photobiomodulation

Interventions

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.

Also known as: Red light therapy, LED light therapy

Photobiomodulation

Eligibility Criteria

• Age: 0 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Paediatric patient receiving a treatment course of either proton or photon therapy - Craniospinal treatment field, Head and Neck treatment fields and body treatment fields.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, Cheshire, M20 4BX, United Kingdom

Location

Related Publications (4)

• Robijns J, Lodewijckx J, Claes S, Van Bever L, Pannekoeke L, Censabella S, Busse L, Colson D, Kaminski I, Broux V, Puts S, Vanmechelen S, Timmermans A, Noe L, Bulens P, Govers M, Maes A, Mebis J. Photobiomodulation therapy for the prevention of acute radiation dermatitis in head and neck cancer patients (DERMISHEAD trial). Radiother Oncol. 2021 May;158:268-275. doi: 10.1016/j.radonc.2021.03.002. Epub 2021 Mar 10.

  PMID: 33711412 BACKGROUND

• Heggie C, Gray-Burrows KA, Day PF, Phillips B. An exploration of the use of photobiomodulation for management of oral mucositis in children and young people undergoing cancer treatment in the UK. Support Care Cancer. 2022 Dec;30(12):10179-10190. doi: 10.1007/s00520-022-07450-3. Epub 2022 Nov 9.

  PMID: 36350380 BACKGROUND

• Gobbo M, Rico V, Marta GN, Caini S, Ryan Wolf J, van den Hurk C, Beveridge M, Lam H, Bonomo P, Chow E, Behroozian T. Photobiomodulation therapy for the prevention of acute radiation dermatitis: a systematic review and meta-analysis. Support Care Cancer. 2023 Mar 23;31(4):227. doi: 10.1007/s00520-023-07673-y.

  PMID: 36952036 BACKGROUND

• Bensadoun RJ, Epstein JB, Nair RG, Barasch A, Raber-Durlacher JE, Migliorati C, Genot-Klastersky MT, Treister N, Arany P, Lodewijckx J, Robijns J; World Association for Laser Therapy (WALT). Safety and efficacy of photobiomodulation therapy in oncology: A systematic review. Cancer Med. 2020 Nov;9(22):8279-8300. doi: 10.1002/cam4.3582. Epub 2020 Oct 26.

  PMID: 33107198 BACKGROUND

MeSH Terms

Conditions

Stomatitis; Esophagitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Ed Smith

  The Christie NHS Foundation Trust

  STUDY DIRECTOR

Central Study Contacts

Natalie Higgins

CONTACT

+44 161 918 2478; removed_due_to_spam@email.com

Ed Smith

CONTACT

+44 161 446 3000; removed_due_to_spam@email.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 19, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)