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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | 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. |
|
| Group II | Experimental | 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. |
|
| Group III | Sham Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Therapy | Device | - Laser will be applied with the specified wave length using a diode laser device over 4 consecutive days. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ebtesam Hanafy | Contact | 25351500 | 7209 | Ebtesam.Hanafy@57357.org |
| Name | Affiliation | Role |
|---|---|---|
| Hussein ElNoury, MSc | NewGiza University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children Cancer Hospital Egypt 57357 | Recruiting | Cairo | Egypt | |||
| Children Cancer Hospital in Egypt 57357 |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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The outcome evaluator will be a single personnel from the oncology team following up with the case.
| Sham procedure | Device | 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 |
|
| Recruiting |
| Cairo |
| Egypt |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |