Clinical trial · Interventional
A Clinical Trial of the Administration of Light Therapy to Prevent Mouth Sores in Children With Cancer
Photobiomodulation Therapy for the Prevention of Mucositis in Pediatric Oncology Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn if light therapy can prevent mouth sores in children with cancer. The main questions it aims to answer are: Is it reasonable and acceptable to provide light therapy for children with cancer? Does light therapy prevent mouth sores related to medical treatment? Researchers will compare children who do not receive light therapy to children who do receive light therapy during the clinical trial to see if light therapy helps to prevent mucositis. Participants will: * Complete a survey. * Have picture taken of their mouth to look for mouth sores. * Receive light therapy every day while admitted to the hospital on the cancer unit or while admitted to an alternate unit, and continue to receive light therapy in the home setting until they reach 8 days after the start of their chemotherapy cycle.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucositis Oral | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photobiomodulation for exploratory arm | Device | — | UNRESOLVED |
| Photobiomodulation for prevention arm | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Prospective data review of patients who did not receive light therapy
- type
- ACTIVE_COMPARATOR
- label
- Prevention Arm
- description
- Prospective data review of patients who did receive light therapy
- interventionNames
- Device: Photobiomodulation for prevention arm
- type
- ACTIVE_COMPARATOR
- label
- Exploratory Arm
- description
- Prospective review of patients with Trisomy 21 who did receive light therapy
- interventionNames
- Device: Photobiomodulation for exploratory arm
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: 1. Current and new diagnosis patients consented upon admission if deemed eligible 2. Ages 0-30 3. Admitted to CW oncology/BMT inpatient unit, PICU, or West 5 4. Chemotherapy regimen: Methotrexate ≥5 g/m2 (or ≥1 g/m2 if Trisomy 21) OR Anthracycline ≥60 mg/m2 5. Able to speak and understand English or Spanish Exclusion Criteria: 1. Patients admitted on BMT service 2. Patients currently experiencing mucositis with a CTCAE grade 4 oral mucositis or higher
References
Publications (17)
- BACKGROUNDJacobs S, Baggott C, Agarwal R, Hesser T, Schechter T, Judd P, Tomlinson D, Beyene J, Sung L. Validation of the Children's International Mucositis Evaluation Scale (ChIMES) in paediatric cancer and SCT. Br J Cancer. 2013 Nov 12;109(10):2515-22. doi: 10.1038/bjc.2013.618. Epub 2013 Oct 15. PMID 24129238
- BACKGROUNDTreister NS, Nieder M, Baggott C, Olson E, Lo T, Jin X, Gao Y, Chen L, Dang H, Sung L. Validation of healthcare professional proxy-reported children's International Mucositis Evaluation Scale. Oral Dis. 2023 Mar;29(2):747-754. doi: 10.1111/odi.13918. Epub 2021 May 26. PMID 33993618
- BACKGROUNDRabin KR, Smith J, Kozinetz CA. Myelosuppression and infectious complications in children with Down syndrome and acute lymphoblastic leukemia. Pediatr Blood Cancer. 2012 Apr;58(4):633-5. doi: 10.1002/pbc.23371. Epub 2011 Nov 21. PMID 22106003
- BACKGROUNDZadik Y, Arany PR, Fregnani ER, Bossi P, Antunes HS, Bensadoun RJ, Gueiros LA, Majorana A, Nair RG, Ranna V, Tissing WJE, Vaddi A, Lubart R, Migliorati CA, Lalla RV, Cheng KKF, Elad S; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. Support Care Cancer. 2019 Oct;27(10):3969-3983. doi: 10.1007/s00520-019-04890-2. Epub 2019 Jul 8. PMID 31286228
- BACKGROUNDTreister NS, London WB, Guo D, Malsch M, Verrill K, Brewer J, Margossian S, Duncan C. A Feasibility Study Evaluating Extraoral Photobiomodulation Therapy for Prevention of Mucositis in Pediatric Hematopoietic Cell Transplantation. Photomed Laser Surg. 2016 Apr;34(4):178-84. doi: 10.1089/pho.2015.4021. Epub 2016 Mar 16. PMID 26982624
- BACKGROUNDMiranda-Silva W, da Fonseca FP, Gomes AA, Mafra ABB, Rocha V, Fregnani ER. Oral mucositis in paediatric cancer patients undergoing allogeneic hematopoietic stem cell transplantation preventively treated with professional dental care and photobiomodulation: Incidence and risk factors. Int J Paediatr Dent. 2022 Mar;32(2):251-263. doi: 10.1111/ipd.12850. Epub 2021 Jul 20.