NCT06623305

A Clinical Trial of the Administration of Light Therapy to Prevent and Treat Mouth Sores in Children With Cancer

Photobiomodulation Therapy for the Prevention and Treatment of Mucositis in Pediatric Oncology Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if light therapy can prevent and/or treat mouth sores in children with cancer. The main questions it aims to answer are: Is it reasonable and acceptable to provide light therapy for children with cancer? Does light therapy prevent and treat mouth sores related to medical treatment? Researchers will compare children who did not receive light therapy before the clinical trial to children who receive light therapy during the clinical trial to see if light therapy helps to prevent and treat mucositis. Participants will: * Tell the nurse their pain score, related to their mouth sores, before receiving light therapy. * Have picture taken of their mouth to look for mouth sores. * Receive light therapy every other day while admitted to the hospital on the cancer unit or while admitted to an alternate unit.

Conditions

• Mucositis Oral

Interventions

Type	Name	Description
DEVICE	Photobiomodulation	Light therapy will be administered using the cluster probe on the external cheeks bilaterally and intraorally using the lollipop probe for patients ≥7 years of age. Patients \< 7 years of age will not receive intraoral treatment with the lollipop. Instead, they will be asked to open their mouth while the covered cluster probe is held externally to treat their intraoral membranes. Each treatment (both external cheeks and intraoral buccal region) will be administered over 1 min with a Modulation Frequency 2.5Hz, Skin Conduction nS 001, and Beam Power mW 000, for a total treatment time of 3 minutes.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2024-10-02
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study