Laser Therapy Effect on Oral Mucositis in Childhood Acute Lymphoblastic Leukemia Patients

Study Overview
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Brief Summary
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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
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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 Pain score using CHIMES, Oral mucositis using NCI-CTCAE scale V5 on days, 0,4,7 and 11. Measuring the duration of the lesion.

Official Title
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Effectiveness of Laser Therapy of Different Wavelengths in Chemotherapy Induced Oral Mucositis in Children With Acute Lymphoblastic Leukemia

Conditions
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Oral Mucositis, Childhood Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Device: Laser Therapy
* Device: Sham procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Acute Lymphoblastic Leukemia in the induction therapy phase and have oral mucositis grade 2 or more. Age: 3-14 years old of both genders. No previous treatment with laser. 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). 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: Patients receiving radiotherapy Received oral Cryotherapy or IV keratinocyte growth factor for oral mucositis Patients with unstable clinical condition (e.g. sepsis) Patients who will be withdrawn from participation according to their request or due to loss in follow up

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>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. | Device: Laser Therapy<br>* - Laser will be applied with the specified wave length using a diode laser device over 4 consecutive days.<br>|
| Experimental: Group II<br>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. | Device: Laser Therapy<br>* - Laser will be applied with the specified wave length using a diode laser device over 4 consecutive days.<br>|
| Sham Comparator: Group III<br>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 | Device: Sham procedure<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment | Assessing the change from baseline pain at day 4. Pain assessment will be done by Children's International Mucositis Evaluation Scale (ChIMES). For children less than 8 years the guardian will assist the child in filling the chart. Pain will be measured on day 0, 4, 7 and 11 | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Mucositis Severity: | Assessing the change in the Oral Mucositis Severity from baseline at day 4. his will be measured using the National Cancer Institute Common Toxicity Criteria for adverse events (NCI-CTCAE) scale version 5 | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Mucositis, Childhood Acute Lymphoblastic Leukemia, Laser therapy, low level laser therapy