Photobiomodulation in the Prevention and Management of Oral Mucositis in Children

Prior treatment

• 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.

Other illness

• History of seizures or epilepsy.
• Any condition that, in the investigator's opinion, would interfere with study participation or safety.
  • Participant Withdrawal Criteria
• Development of a new medical condition that, per investigator judgment, contraindicates continuation.

Other

• Documented primary immunodeficiency.
• 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.

• 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.