Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT07183267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D004941', 'term': 'Esophagitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 248}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-08-14', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Paediatric Participants with Treatment-Related Skin Toxicity as Assessed by RTOG', 'timeFrame': 'The participant will be assessed from day one until the end of their proton or photon radiotherapy treatment course, up to 8 weeks.', 'description': 'RTOG Skin Toxicity score range:\n\nGrade 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.'}], 'secondaryOutcomes': [{'measure': 'Number of Head and Neck Participants with Treatment-Related Mucositis as Assessed by CTCAE v4.0', 'timeFrame': 'The participant will be assessed from day one until the end of their proton or photon radiotherapy treatment course, up to 8 weeks.', 'description': 'CTCAE mucositis scoring scale:\n\nGrade 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.\n\nGrade 3: Severe pain; interfering with oral intake. Grade 4: Life-threatening consequences; urgent intervention indicated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Paediatric skin toxicity', 'paediatric oral mucositis', 'paediatric proton therapy', 'paediatric radiotherapy', 'paediatric photon therapy'], 'conditions': ['Radio Dermatitis', 'Mucositis Oral', 'Oesophagitis']}, 'referencesModule': {'references': [{'pmid': '33711412', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36350380', 'type': 'BACKGROUND', 'citation': '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': '36952036', 'type': 'BACKGROUND', 'citation': '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': '33107198', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAll 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.\n\nThe main questions it aims to answer are:\n\n1. Does the use of red light therapy help the skin side effects in children and young people undergoing proton or photon therapy?\n2. 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?\n\nResearchers 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.\n\nParticipants will have a daily treatment with red light therapy alongside their daily proton or photon treatment fraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Paediatric patient receiving a treatment course of either proton or photon therapy - Craniospinal treatment field, Head and Neck treatment fields and body treatment fields.\n\nExclusion Criteria:\n\n* Paediatric patients receiving focal brain only proton or photon radiotherapy.\n* Paediatric patients receiving a single fraction of proton or photon therapy.\n* Total Body Irradiation patients.'}, 'identificationModule': {'nctId': 'NCT07183267', 'acronym': 'RADIANT', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'The Christie NHS Foundation Trust'}, 'officialTitle': 'Reducing rAdiation aDverse Effects of dermatitIs and mucosAl inflammatioN Using Red Light Therapy', 'orgStudyIdInfo': {'id': 'CFTSp248'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Photobiomodulation', 'description': 'Participants will received 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.', 'interventionNames': ['Device: Photobiomodulation']}], 'interventions': [{'name': 'Photobiomodulation', 'type': 'DEVICE', 'otherNames': ['Red light therapy', 'LED light therapy'], 'description': 'Participants will received 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.', 'armGroupLabels': ['Photobiomodulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'Cheshire', 'country': 'United Kingdom', 'contacts': [{'name': 'Natalie Higgins, Msc', 'role': 'CONTACT', 'email': 'natalie.higgins4@nhs.net', 'phone': '+44 161 918 2478'}, {'name': 'Ed Smith', 'role': 'CONTACT', 'email': 'natalie.higgins4@nhs.net', 'phone': '+44 161 446 3000'}, {'name': 'Ed Smith', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Natalie Higgins', 'role': 'CONTACT', 'email': 'removed_due_to_spam@email.com', 'phone': '+44 161 918 2478'}, {'name': 'Ed Smith', 'role': 'CONTACT', 'email': 'removed_due_to_spam@email.com', 'phone': '+44 161 446 3000'}], 'overallOfficials': [{'name': 'Ed Smith', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Christie NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Christie NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}