ClinicalTrials.gg
Sign In
Not yet recruitingNCT07183267RADIANTUpdated Mar 19, 2026

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

An interventional study of Photobiomodulation in Radio Dermatitis, Mucositis Oral and Oesophagitis, sponsored by The Christie NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 0 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by The Christie NHS Foundation Trust · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
248
Allocation
Not applicable
Ages
0 Years to 16 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Radio Dermatitis
  • Mucositis Oral
  • Oesophagitis

Keywords

  • Paediatric skin toxicity
  • paediatric oral mucositis
  • paediatric proton therapy
  • paediatric radiotherapy
  • paediatric photon therapy
03

In context

Stomatitis

306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.

This study's planned enrollment of 248 is above the median of 60 across 276 interventional studies indexed under Stomatitis.

Browse Stomatitis studies →

Lead sponsor

The Christie NHS Foundation Trust is the lead sponsor of 100 studies on the registry; 25 are open to participants now.

Browse The Christie NHS Foundation Trust studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
248 participants (estimated)

Study arms

  • Experimental
    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.

    Device: Photobiomodulation

Interventions

  • DevicePhotobiomodulation

    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

06

What researchers measure

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.

    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

  1. 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.

    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.

07

Study locations

1 site
08

References and documents

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. Epub 2021 Mar 10. PubMed 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. PubMed 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. PubMed 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. PubMed 33107198 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Jun 2028, 24 months later.

Of 65 non-industry interventional studies with no phase under Stomatitis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's planned 24 months is above that.

Counting every sponsor, half of 73 studies reached it within 14 months; a quarter within 10 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2025
First posted
Sep 19, 2025
StartEst.
Jun 1, 2026
Primary completionEst.
Jun 1, 2028
CompletionEst.
Oct 1, 2028
Last update
Mar 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07183267
Lead sponsor
The Christie NHS Foundation Trust
Responsible party
Sponsor
First posted
Sep 19, 2025
Start date
Jun 1, 2026 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Oct 1, 2028 (estimated)
Last update
Mar 19, 2026

Study contacts

Natalie Higgins
Contact
removed_due_to_spam@email.com
+44 161 918 2478
Ed Smith
Contact
removed_due_to_spam@email.com
+44 161 446 3000
Ed Smith
study director · The Christie NHS Foundation Trust

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stomatitis →

Other studies from this sponsor

The Christie NHS Foundation Trust →

Start the discussion