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NCT07372443

Photobiomodulation in the Prevention and Management of Oral Mucositis in Children

Sponsor: Universidad de Guanajuato

View on ClinicalTrials.gov

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.

Official title: Usefulness of Photobio-modulation in the Prevention and Management of Oral Mucositis in Pediatric Patients Undergoing Antineoplastic Treatment: Randomized Clinical Trial

Key Details

Gender

All

Age Range

4 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01

Completion Date

2027-08

Last Updated

2026-01-28

Healthy Volunteers

Conditions

Oral Mucositis Chemotherapy Effect Pediatric Cancer

Interventions

DEVICE

Photobiomodulation

For the prevention arm, photobiomodulation will be applied three alternate days per week starting on the first three days of chemotherapy. It will be applied to areas such as the corners of the mouth, the lip mucosa, the buccal mucosa, the lateral edges of the tongue, the ventral tongue, the anterior floor of the mouth, and the soft palate. For the treatment arm, photobiomodulation will be applied every other day of the week from the detection of oral mucositis until resolution. The application sites will be the affected mucosal areas, whether they present erythema or ulcerations.

DRUG

bioadhesive gel

Application of bioadherent gel Rinse with bioadherent gel, 5 consecutive days, 30 to 60 minutes before each meal. Or apply with a swab in young children who are unable to rinse.

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 investigator's judgment, contraindicates participation. * No photobiomodulation (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. Exclusion Criteria: * Documented primary immunodeficiency. * Severe concomitant systemic infection or unstable medical condition. * PBM treatment within 14 days prior to enrollment. * Known photosensitivity or prior adverse reaction to light therapy. * History of seizures or epilepsy. * Any condition that, in the investigator's opinion, would interfere with study participation or safety. Participant Withdrawal Criteria * Attendance to fewer than 80% of scheduled treatment sessions. * Any adverse event or persistent discomfort attributed to PBM that leads the participant or guardian to decline further intervention. * Withdrawal of consent by parent/guardian or assent withdrawal by participant when applicable. * Development of a new medical condition that, per investigator judgment, contraindicates continuation.