Photobiomodulation in the Prevention and Management of Oral Mucositis in Children

Sponsor
Universidad de Guanajuato
Study ID
NCT07372443
Status
Not Yet Recruiting

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Conditions

  • Chemotherapy Effect
  • Oral Mucositis
  • Pediatric Cancer

Eligibility Criteria

Sex
ALL
Age
4 Years - 17 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Jan 28, 2026
Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
49 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

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

Primary Outcome Measure

Oral mucositis grade [ Time Frame: Days 7, 11, 14, and 21 after intervention initiation for each episode/cycle (each cycle is 14 days) ]

Central Contacts

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