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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-16
SponsorThe Christie NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

248 Participants
are divided into 1 treatment group
Group A: PhotobiomodulationExperimental treatment 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: