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

NCT06267417 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-08-21

No results posted yet for this study

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.

Conditions

  • Oral Mucositis

Interventions

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

DEVICE

Mock treatment

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

Sponsors & Collaborators

  • Children's Cancer Hospital Egypt 57357

    lead OTHER

Principal Investigators

  • Reem Elkady, MSc · Misr International University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-10
Primary Completion
2023-07-01
Completion
2023-11-08

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267417 on ClinicalTrials.gov