Laser Therapy Effect as Preventive Measure for Oral Mucositis in Children With Hematological Malignancies

Oral Mucositis Clinical Trial

Official title:

Evaluation of The Effect of Low Level Laser Therapy in The Prevention of Chemotherapy Induced Oral Mucositis in Children With Hematological Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267417
• Other study ID #: CCHE-AML-4/2023
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Children's Cancer Hospital Egypt 57357
• Contact: Reem Elkady
• Phone: 01004925637
• Email: relkady100[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction:

Among the most drastic complications of chemotherapy is oral mucositis(OM). 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 therapy(LLLT) 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 children's 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.

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 1,5,12,19 and 30 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 31, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• pediatric patients diagnosed with Acute Myeloid Leukemia.

• Children with a minimum age of 3 years and a maximum 18 years.

• Children with sufficient cooperation to accept the treatment and evaluation periods

Exclusion Criteria:

• Patients with limited mouth openings less than 1 cm, due to difficulty of laser radiation.

• Patients with dysplastic oral lesions.

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Device:
• Laser therapy
- Laser will be applied with the specified wave length using Diode laser (Sirrolaser Blue ™, USA) device over 5 consecutive days from start of chemotherapy cycle beside the standard preventive protocol applied in the hospital
• Mock treatment
The exact repetition of the treatment modality but without any laser emission beside the standard preventive protocol applied in the hospital

Locations

Country	Name	City	State
Egypt	Children Cancer Hospital 57357	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer Hospital Egypt 57357

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure incidence of oral mucositis in Laser arm versus Placebo arm.	Evaluate effectiveness of low level laser therapy for the Prevention of chemo-therapy induced oral mucositis.	Oral mucositis will be evaluated on Days 1, 5, 12, 19 and 30.
Primary	To measure grade of oral mucositis in patients receiving laser arm placebo arm.	Oral mucositis will be graded in accordance with the classification criteria of the World Health Organization (WHO, and the National Cancer Institute scale (NCI - Common Terminology Criteria for Adverse Events, version 4.0) will also be used to compare the results.	Oral mucositis will be evaluated on Days 1, 5, 12, 19 and 30.