High-level laser therapy for oral mucositis in children receiving hematopoietic stem cell transplant
Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Clinical Trial
This trial tests whether high-level laser therapy can reduce the pain and severity of oral mucositis in children undergoing hematopoietic stem cell (bone marrow) transplantation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07436650 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls pediatric patients under 18 who develop WHO grade II or higher oral mucositis during hematopoietic stem cell transplantation. Participants receive high-level laser therapy applied to lesion sites for four consecutive days and are compared with patients receiving basic oral care, with outcomes recorded on the WHO oral mucositis scale. Follow-up visits occur at 7 and 11 days after enrolment to measure changes in severity and healing. Key exclusions include prior photobiomodulation, limited mouth opening, dysplastic oral lesions, and prior head and neck radiotherapy.
Who should consider this trial
Good fit: Children under 18 undergoing bone marrow/hematopoietic stem cell transplant who develop WHO grade II or higher oral mucositis and can attend four consecutive treatment days plus follow-up visits.
Not a fit: Patients with prior photobiomodulation, mouth opening less than 2 cm, dysplastic oral lesions, prior head/neck radiation, or those unable to consent/participate are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If effective, the therapy could shorten the duration and reduce the severity and pain of oral mucositis, improving eating comfort and reducing supportive care needs.
How similar studies have performed: Low-level laser (photobiomodulation) has shown benefit for oral mucositis in multiple studies, but use of high-power laser specifically in pediatric HSCT patients is less well studied and evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children under the age of 18 years undergoing bone marrow transplantation during the phase of oral mucositis. * Oral mucositis starting from grade II on the WHO scale for OM. * Willingness to undergo treatment for four consecutive days and to return for evaluation 7 and 11 days after enrolment. Exclusion Criteria: * Previous treatment with photobiomodulation for oral mucositis. * Limited mouth opening less than 2 cm. * Presence of dysplastic oral lesions. * Radiotherapy in the head and neck area. * Vulnerable groups of patients or decision-impaired individuals as prisoners, handicapped and mentally retarded individuals
Where this trial is running
Cairo, Cairo Governorate
- Oncology and Bone marrow transplant unit, Children's hospital, Ain Shams University — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Asmaa Ayman Gabr, Teaching Assistant
- Email: Asmaagabr@dent.asu.edu.eg
- Phone: +2 01095692889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.