Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-26 @ 8:03 PM
Study NCT ID:
NCT05452668
Status:
UNKNOWN
Last Update Posted:
2024-08-21
First Post:
2022-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Therapy Effect on Oral Mucositis in Childhood Acute Lymphoblastic Leukemia Patients
Sponsor:
Children's Cancer Hospital Egypt 57357
Organization:
Study Overview
Official Title:
Effectiveness of Laser Therapy of Different Wavelengths in Chemotherapy Induced Oral Mucositis in Children With Acute Lymphoblastic Leukemia
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: