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

NCT06267417 | Completed DMC

• 1 other identifier: CCHE-AML-4/2023
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis

Keywords

low level laser therapy; oral mucositis

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

Laser

EXPERIMENTAL

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.

Device: Laser therapy

Placebo

SHAM COMPARATOR

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.

Device: Mock treatment

Interventions

Laser therapy 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

Laser

Mock treatment DEVICE

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

Placebo

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Cancer Hospital Egypt 57357: lead

Study Sites (1)

Children Cancer Hospital 57357

Cairo, 11617, Egypt

Location

MeSH Terms

Conditions

Stomatitis

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Reem Elkady, MSc

  Misr International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The outcome evaluator will be a single personnel from the oncology team following up with the case
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: February 20, 2024
• Study Start: April 10, 2023
• Primary Completion: July 1, 2023
• Study Completion: November 8, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-02

Locations

EG (1)