Clinical trial NCT06267417: Laser Therapy Effect as Preventive Measure for Oral Mucositis in Children With Hematological Malignancies
Official title: Evaluation of The Effect of Low Level Laser Therapy in The Prevention of Chemotherapy Induced Oral Mucositis in Children With Hematological Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Keywords: low level laser therapy
oral mucositis
Lead sponsor: Children's Cancer Hospital Egypt 57357
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 42
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 .

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.

Primary outcomes:
measure: To measure incidence of oral mucositis in Laser arm versus Placebo arm.
timeFrame: Oral mucositis will be evaluated on Days 1, 5, 12, 19 and 30.
measure: To measure grade of oral mucositis in patients receiving laser arm placebo arm.
timeFrame: Oral mucositis will be evaluated on Days 1, 5, 12, 19 and 30.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children Cancer Hospital 57357
Study officials:
affiliation: Misr International University
name: Reem Elkady, MSc
role: PRINCIPAL_INVESTIGATOR
References: