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

NCT ID: NCT06267417

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2023-11-08

Brief 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.

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 1,5,12,19 and 30 .

Conditions

Oral Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Laser

21 patients will receive Low Level Laser therapy using the wavelength (660 nm) to provide biostimulation at 44 different points in the oral cavity along with the standard preventive protocol in the hospital.

Group Type: EXPERIMENTAL

Laser therapy

Intervention Type: DEVICE

\- 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

Placebo

21 patients 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.

Group Type: SHAM_COMPARATOR

Mock treatment

Intervention Type: DEVICE

The exact repetition of the treatment modality but without any laser emission beside the standard preventive protocol applied in the hospital

Interventions

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

Intervention Type: DEVICE

Mock treatment

The exact repetition of the treatment modality but without any laser emission beside the standard preventive protocol applied in the hospital

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Cancer Hospital Egypt 57357

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reem Elkady, MSc

Role: PRINCIPAL_INVESTIGATOR

Misr International University

Locations

Children Cancer Hospital 57357

Cairo, , Egypt

Countries

Egypt

Other Identifiers

CCHE-AML-4/2023

Identifier Type: -

Identifier Source: org_study_id