Photobiomodulation in the Prevention and Management of Oral Mucositis in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorUniversidad de Guanajuato
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Photobiomodulation
DeviceFor 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.
bioadhesive gel
DrugApplication 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.
Treatment groups
49 Participants
are divided into 2 treatment groupsGroup A: Prevention armExperimental treatment 2 interventions
Group B: TreatmentExperimental treatment 2 interventions
Trial outcomes
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
Time frame
Days 7, 11, 14, and 21 after intervention initiation for each episode/cycle (each cycle is 14 days)Secondary outcomes
1
Incidence of oral mucositis
Proportion of chemotherapy cycles in which participants develop oral mucositis defined as WHO grade ≥1; assessments by blinded clinician
Time frame
Per chemotherapy cycle and overall study period (up to 21 days post intervention).2
Oral mucositis Duration outcome
time from onset of WHO grade ≥1 mucositis to resolution to WHO grade 0.
Time frame
Mesured for each episode during follow-upLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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