NCT05452668

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Children's Cancer Hospital Egypt 57357 · Academic / Other
• Sex: All
• Age: 3 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 14 years 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, 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 1. Pain score using CHIMES, 2. Oral mucositis using NCI-CTCAE scale V5 on days, 0,4,7 and 11. 3. Measuring the duration of the lesion.

Conditions

• Oral Mucositis
• Childhood Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DEVICE	Laser Therapy	\- Laser will be applied with the specified wave length using a diode laser device over 4 consecutive days.
DEVICE	Sham procedure	Seventeen patients will receive mock treatment which is the exact repetition of the treatment modality but without any laser emission plus the current Protocol(antifungal +/- antiviral and analgesics) used by CCHE which will be recorded in the patient's file

Timeline

• Start date: 2023-05-16
• Primary completion: 2024-12-01
• Completion: 2024-12-30
• First posted: 2022-07-11
• Last updated: 2024-08-21

Locations

2 sites across 1 country: Egypt