Photobiomodulation in the Prevention and Management of Oral Mucositis in Children (NCT07372443) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Photobiomodulation in the Prevention and Management of Oral Mucositis in Children
49 participantsStarted 2026-01
Plain-language summary
Oral mucositis (OM) is a frequent, debilitating complication in pediatric oncology that impairs quality of life, nutrition, hydration, and treatment adherence. This randomized, prospective, single blind trial in Mexico will evaluate photobiomodulation (PBM) versus a conventional bioadhesive gel for prevention and treatment of antineoplastic therapy-induced OM in children aged 4-17 with leukemia, lymphoma, or head and neck tumors. A total of 49 participants will be enrolled. The study has two components: (1) Treatment - parallel comparison of PBM versus bioadhesive gel for established OM; (2) Prevention - crossover design in which patients receive both interventions across successive chemotherapy cycles. PBM will be delivered with a 660 nm device, 40 mW, 10 J/cm². The primary outcome is OM grade by the WHO scale assessed on days 7, 11, 14, and 21. Expected results include reduced OM incidence, severity, duration, and pain with favorable safety and tolerability, supporting standardized PBM protocols in pediatric oncology in Mexico.
Who can participate
Age range
4 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Prevention Arm - Inclusion Criteria
* Age 4 to 17 years
* Histopathologic diagnosis of malignant neoplasm: leukemia, lymphoma, or solid tumor of the head and neck.
* Within days 1-3 of the start of any chemotherapy cycle; for leukemia patients, in consolidation phase as defined by protocol.
* No signs of oral mucositis at enrollment.
* Availability and willingness to attend scheduled photobiomodulation (PBM) application sessions.
* Parent/legal guardian signed informed consent and child assent when applicable (≥ 8 years).
* No documented primary immunodeficiency.
* No severe concomitant systemic infection or medical condition that, in the investigator's judgment, contraindicates participation.
* No PBM treatment within 14 days prior to enrollment.
* No history of adverse reactions to light therapies or known photosensitivity.
* No history of seizure disorder or diagnosis of epilepsy.
Treatment Arm - Inclusion Criteria
* Age 4 to 17 years
* Histopathologic diagnosis of malignant neoplasm: leukemia, lymphoma, or solid tumor of the head and neck.
* Currently receiving chemotherapy (any cycle of the regimen).
* Presence of oral mucositis of any grade during chemotherapy, identified within the first 3 days from onset of the mucositis episode.
* Parent/legal guardian signed informed consent and child assent when applicable (≥ 8 years).
* No documented primary immunodeficiency.
* No severe concomitant systemic infection or medical condition that, in the inves…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oral mucositis grade
Timeframe: Days 7, 11, 14, and 21 after intervention initiation for each episode/cycle (each cycle is 14 days)