Clinical trial · Interventional
Laser Therapy Effect as Preventive Measure for Oral Mucositis in Children With Hematological Malignancies
Evaluation of The Effect of Low Level Laser Therapy in The Prevention of Chemotherapy Induced Oral Mucositis in Children With Hematological Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Introduction: Among the most drastic complications of chemotherapy is oral mucositis(OM). It is a painful inflammatory, often ulcerative condition and may increase risk for systemic infections leading to prolonged hospital stays and interruptions of treatment protocol. Many treatment modalities have been introduced for the prevention and treatment of oral mucositis , of which low level laser therapy(LLLT) is gaining popularity. The use of LLLT as a prophylactic treatment for chemotherapy induced oral mucositis in pediatric cancer patients is still lacking robust evidence. Also, the parameters used have not been optimized and no standard method has yet been established. Based on this point, this study will compare photobiomodulation to the conventional preventive program of oral mucositis applied in 57357 children's cancer hospital foundation to determine which will be optimal for the prophylaxis of chemotherapy-induced OM. Aim: To assess the effectiveness of low level laser therapy in the prophylaxis of oral mucositis in pediatric patients diagnosed with Hematological cancers. Methods: This study is a randomized, prospective, double-blinded trial that will include acute Myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years. These patients will be randomized into two groups: group 1 will receive low level laser therapy and group 2 will receive mock treatment. Patient will be followed to asses the development of oral mucositis on prespecified time points.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser therapy | Device | — | UNRESOLVED |
| Mock treatment | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laser
- description
- 21 patients will receive Low Level Laser therapy using the wavelength (660 nm) to provide biostimulation at 44 different points in the oral cavity along with the standard preventive protocol in the hospital.
- interventionNames
- Device: Laser therapy
- type
- SHAM_COMPARATOR
- label
- Placebo
- description
- 21 patients will receive a mock treatment which is the exact repetition of the treatment modality but without any laser emission beside the standard preventive protocol applied in the hospital.
- interventionNames
- Device: Mock treatment
Primary outcomes (2)
- measure
- To measure incidence of oral mucositis in Laser arm versus Placebo arm.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * pediatric patients diagnosed with Acute Myeloid Leukemia. * Children with a minimum age of 3 years and a maximum 18 years. * Children with sufficient cooperation to accept the treatment and evaluation periods Exclusion Criteria: * Patients with limited mouth openings less than 1 cm, due to difficulty of laser radiation. * Patients with dysplastic oral lesions.
References
Publications (0)
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