Photobiomodulation in the Prevention and Management of Oral Mucositis in Children

NCT07372443 | Not Yet Recruiting DMC

• 1 other identifier: MX-UG-PBM-PED-2025-001
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Oral Mucositis; Chemotherapy Effect; Pediatric Cancer

Keywords

Photobiomodulation

Outcome Measures

Primary Outcomes (1)

• Oral mucositis grade

  Grade of oral mucositis assessed using the World Health Organization (WHO) oral mucositis scale (0-4). Assessments performed by a blinded clinician trained in the scale

  Days 7, 11, 14, and 21 after intervention initiation for each episode/cycle (each cycle is 14 days)

Secondary Outcomes (2)

• Incidence of oral mucositis

  Per chemotherapy cycle and overall study period (up to 21 days post intervention).

• Oral mucositis Duration outcome

  Mesured for each episode during follow-up

Study Arms (2)

Prevention arm

EXPERIMENTAL

Cross-over design: patients receive both interventions (photobiomodulation in the first phase and are reassigned to receive bioadhesive gel in the second phase), i.e., in successive cycles of chemotherapy, within the first three days of the start of chemotherapy, in the absence of oral mucositis.

Device: Photobiomodulation; Drug: bioadhesive gel

Treatment

EXPERIMENTAL

Treatment arm: randomization into two groups: one receives photobiomodulation, and the other receives bioadhesive gel, in the presence of oral mucositis.

Device: Photobiomodulation; Drug: bioadhesive gel

Interventions

Photobiomodulation DEVICE

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.

Prevention arm; Treatment

bioadhesive gel DRUG

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.

Prevention arm; Treatment

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Guanajuato: lead

MeSH Terms

Conditions

Stomatitis; Neoplasms

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• María C Palacios, PhD

  Universidad de Guanajuato

  STUDY DIRECTOR

Central Study Contacts

Mariana P Rodríguez, MSc

CONTACT

+52 4737387357; mp.rodriguezvargas@ugto.mx

María C Palacios, PhD

CONTACT

+52 477 7143812; mdc.palacios@ugto.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding: open for the principal investigator, who will be aware of the intervention, and blinded to the evaluator.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Simple-blind randomized clinical trial. Two arms: Treatment (parallel design). Prevention (crossover design).

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 28, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share