Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06267417
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2023-07-24
Brief Title:
Laser Therapy Effect as Preventive Measure for Oral Mucositis in Children With Hematological Malignancies
Sponsor:
Childrens Cancer Hospital Egypt 57357
Organization:
Childrens Cancer Hospital Egypt 57357
Study Overview
Official Title:
Evaluation of The Effect of Low Level Laser Therapy in The Prevention of Chemotherapy Induced Oral Mucositis in Children With Hematological Cancers
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
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
Among the most drastic complications of chemotherapy is oral mucositisOM It is a painful inflammatory often ulcerative condition and may increase risk for systemic infections leading to prolonged hospital stays and interruptions of treatment protocol Many treatment modalities have been introduced for the prevention and treatment of oral mucositis of which low level laser therapyLLLT is gaining popularity The use of LLLT as a prophylactic treatment for chemotherapy induced oral mucositis in pediatric cancer patients is still lacking robust evidence Also the parameters used have not been optimized and no standard method has yet been established Based on this point this study will compare photobiomodulation to the conventional preventive program of oral mucositis applied in 57357 childrens cancer hospital foundation to determine which will be optimal for the prophylaxis of chemotherapy-induced OM
Aim
To assess the effectiveness of low level laser therapy in the prophylaxis of oral mucositis in pediatric patients diagnosed with Hematological cancers
Methods
This study is a randomized prospective double-blinded trial that will include acute Myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years These patients will be randomized into two groups group 1 will receive low level laser therapy and group 2 will receive mock treatment Patient will be followed to asses the development of oral mucositis on prespecified time points
Among the most drastic complications of chemotherapy is oral mucositisOM It is a painful inflammatory often ulcerative condition and may increase risk for systemic infections leading to prolonged hospital stays and interruptions of treatment protocol Many treatment modalities have been introduced for the prevention and treatment of oral mucositis of which low level laser therapyLLLT is gaining popularity The use of LLLT as a prophylactic treatment for chemotherapy induced oral mucositis in pediatric cancer patients is still lacking robust evidence Also the parameters used have not been optimized and no standard method has yet been established Based on this point this study will compare photobiomodulation to the conventional preventive program of oral mucositis applied in 57357 childrens cancer hospital foundation to determine which will be optimal for the prophylaxis of chemotherapy-induced OM
Aim
To assess the effectiveness of low level laser therapy in the prophylaxis of oral mucositis in pediatric patients diagnosed with Hematological cancers
Methods
This study is a randomized prospective double-blinded trial that will include acute Myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years These patients will be randomized into two groups group 1 will receive low level laser therapy and group 2 will receive mock treatment Patient will be followed to asses the development of oral mucositis on prespecified time points
Detailed Description:
This study is a randomized prospective double-blinded trial patient outcome assessor that will include acute Myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years These patients will be randomized by the Clinical Epidemiology unit using a computer-based method into two groups
Group I will receive Low Level Laser Therapy by Diode laser Sirrolaser Blue USA at 44 different points in the oral cavity for 5 consequent days from Day 1 to Day 5 of chemotherapy cycle along with the standard preventive protocol in the hospital
Group II will receive a mock treatment which is the exact repetition of the treatment modality but without any laser emission beside the standard preventive protocol applied in the hospital
All patients will be assessed for oral mucositis grade using NCI-CTCAE scale V4 and WHO score on days 151219 and 30
Group I will receive Low Level Laser Therapy by Diode laser Sirrolaser Blue USA at 44 different points in the oral cavity for 5 consequent days from Day 1 to Day 5 of chemotherapy cycle along with the standard preventive protocol in the hospital
Group II will receive a mock treatment which is the exact repetition of the treatment modality but without any laser emission beside the standard preventive protocol applied in the hospital
All patients will be assessed for oral mucositis grade using NCI-CTCAE scale V4 and WHO score on days 151219 and 30
Study Oversight
Has Oversight DMC:
None
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?:
None