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

Sponsor
The Christie NHS Foundation Trust
Study ID
NCT07183267
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
0 Years - 16 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
248 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

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.

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. ]

Central Contacts

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