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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Photobiomodulation.
- Who it may be relevant to
- Registry conditions: Radio Dermatitis, Mucositis Oral, Oesophagitis. Basic parameters: 0 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Reducing rAdiation aDverse Effects of dermatitIs and mucosAl inflammatioN Using Red Light Therapy
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.
Interventions
- Device Photobiomodulation
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.
Primary outcome measures
- 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.]
Secondary outcome measures (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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United Kingdom · 1 center
- The Christie NHS Foundation Trust — Manchester
Publications
- 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. E PMID 33711412
- 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
- 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
- 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
Identifiers
NCT: NCT07183267 · CFTSp248