Radio DermatitisRADIANTNCT07183267
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
A study testing Photobiomodulation in people with Radio Dermatitis and Mucositis Oral, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- Radio Dermatitis, Mucositis Oral, Oesophagitis
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Paediatric patient receiving a treatment course of either proton or photon therapy - Craniospinal treatment field, Head and Neck treatment fields and body treatment fields.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, Cheshire, M20 4BX
Natalie Higgins, Msc, +44 161 918 2478, natalie.higgins4@nhs.net
Ed Smith, +44 161 446 3000, natalie.higgins4@nhs.net
About this study
Official title: Reducing rAdiation aDverse Effects of dermatitIs and mucosAl inflammatioN Using Red Light Therapy
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.
Read more
The main questions it aims to answer are:
- Does the use of red light therapy help the skin side effects in children and young people undergoing proton or photon therapy?
- 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.
- Conditions
- Radio Dermatitis, Mucositis Oral, Oesophagitis
- Being tested
- Photobiomodulation
- Keywords
- Paediatric skin toxicity, paediatric oral mucositis, paediatric proton therapy, paediatric radiotherapy, paediatric photon therapy
- Medical subject headings
- Stomatitis, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Also called Red light therapy, LED light therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The participant will be assessed from day one until the end of their proton or photon radiotherapy treatment course, up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Radio DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ed Smith, Study director, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183267
- Sponsor's protocol ID
- CFTSp248
- Acronym
- RADIANT
- Status last verified
- Mar 2026
- First submitted
- 14 Aug 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 33711412Heggie 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 36350380Gobbo 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 36952036Bensadoun 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing rAdiation aDverse Effects of dermatitIs and mucosAl inflammatioN Using Red Light Therapy
- ClinicalTrials.gov ID
- NCT07183267
- Acronym / sponsor ID
- RADIANT / CFTSp248
- Conditions
- Radio Dermatitis, Mucositis Oral, Oesophagitis
- Keywords
- Paediatric skin toxicity, paediatric oral mucositis, paediatric proton therapy, paediatric radiotherapy, paediatric photon therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the use of red light therapy help the skin side effects in children and young people undergoing proton or photon therapy?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Experimental | Device: PhotobiomodulationParticipants 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. |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Paediatric patient receiving a treatment course of either proton or photon therapy - Craniospinal treatment field, Head and Neck treatment fields and body treatment fields.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationAlso: Red light therapy, LED light therapyParticipants 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 |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 33711412Robijns 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.
- Background: PubMed 36350380Heggie 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.
- Background: PubMed 36952036Gobbo 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.
- Background: PubMed 33107198Bensadoun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ed Smith study director
The Christie NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Radio Dermatitis and Mucositis Oral, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalie Higgins (+44 161 918 2478, removed_due_to_spam@email.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07183267, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.