Clinical trial · Interventional
Laser Therapy Effect on Oral Mucositis in Childhood Acute Lymphoblastic Leukemia Patients
Effectiveness of Laser Therapy of Different Wavelengths in Chemotherapy Induced Oral Mucositis in Children With Acute Lymphoblastic Leukemia
- 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: Oral mucositis is one of the most frequent complications associated with chemotherapy, occurring in up to 90% children receiving treatment for cancer. Different treatment modalities have been suggested with inconsistent results. Recently, it has been suggested that the use of laser could reduce the grade of oral mucositis and alleviate the symptoms. Aim: To evaluate and compare the efficacy between the high (Infrared) wavelength laser and low (red) wavelength laser in management of chemotherapy induced oral mucositis in children with acute lymphoblastic leukemia. Methods: This study is a randomized, prospective, double-blind trial that will include acute lymphoblastic leukemia inpatients receiving induction chemotherapy between the age of 3 and 14years who develop oral mucositis grade 2 or more. These patients will be randomized by the Clinical Epidemiology unit using a computer-based method into three groups. Group I: will be treated with Laser wavelength 660 nm, group II: will be treated with laser wavelength 970 nm, and group III: will receive mock treatment which is the exact repetition of the treatment modality but without any laser emission. All the patients will follow the hospital standard management for oral mucositis. All patients will be assessed for pain score using CHIMES, oral mucositis using NCI-CTCAE scale V5 on days, 0,4,7 and 11. As well as measuring the duration of the lesion.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser Therapy | Device | — | UNRESOLVED |
| Sham procedure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group I
- description
- Seventeen patients will receive treatment using the red wavelength (660 nm) to provide biostimulation. Plus the current protocol (antifungal +/- antiviral and analgesics) used by CCHE which will be recorded in the patient's file.
- interventionNames
- Device: Laser Therapy
- type
- EXPERIMENTAL
- label
- Group II
- description
- Seventeen patients will receive treatment using the infrared wavelength (970 nm) to provide biosstimulation. plus the current protocol(antifungal +/- antiviral and analgesics) used by CCHE which will be recorded in the patient's file.
- interventionNames
- Device: Laser Therapy
- type
- SHAM_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with Acute Lymphoblastic Leukemia in the induction therapy phase and have oral mucositis grade 2 or more. 2. Age: 3-14 years old of both genders. 3. No previous treatment with laser. 4. Ability to open mouth for more than 2 cm for the duration of laser application with a level of cooperation (Frankl rating 3 or 4). 5. Patients who still have 10 days in their induction therapy phase or can be followed up for a mininum of 10 days after the development of oral mucositis Exclusion Criteria: 1. Patients receiving radiotherapy 2. Received oral Cryotherapy or IV keratinocyte growth factor for oral mucositis 3. Patients with unstable clinical condition (e.g. sepsis) 4. Patients who will be withdrawn from participation according to their request or due to loss in follow up
References
Publications (0)
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