Laser Therapy Effect on Oral Mucositis in Childhood Acute Lymphoblastic Leukemia Patients

NCT ID: NCT05452668

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2024-12-30

Brief Summary

Introduction: Oral mucositis is one of the most frequent complications associated with chemotherapy, occurring in up to 90% children receiving treatment for cancer. Different treatment modalities have been suggested with inconsistent results. Recently, it has been suggested that the use of laser could reduce the grade of oral mucositis and alleviate the symptoms.

Aim: To evaluate and compare the efficacy between the high (Infrared) wavelength laser and low (red) wavelength laser in management of chemotherapy induced oral mucositis in children with acute lymphoblastic leukemia.

Methods: This study is a randomized, prospective, double-blind trial that will include acute lymphoblastic leukemia inpatients receiving induction chemotherapy between the age of 3 and 14years who develop oral mucositis grade 2 or more. These patients will be randomized by the Clinical Epidemiology unit using a computer-based method into three groups. Group I: will be treated with Laser wavelength 660 nm, group II: will be treated with laser wavelength 970 nm, and group III: will receive mock treatment which is the exact repetition of the treatment modality but without any laser emission. All the patients will follow the hospital standard management for oral mucositis. All patients will be assessed for pain score using CHIMES, oral mucositis using NCI-CTCAE scale V5 on days, 0,4,7 and 11. As well as measuring the duration of the lesion.

Detailed Description

This study is a randomized, prospective, double-blind trial that will include acute lymphoblastic leukemia inpatients receiving induction chemotherapy between the age of 3 and 14 years who develop oral mucositis grade 2 or more. These patients will be randomized by the Clinical Epidemiology unit using a computer-based method into three groups.

Group I: will be treated with Laser wavelength 660 nm, Group II: will be treated with laser wavelength 970 nm, Group III: will receive mock treatment which is the exact repetition of the treatment modality but without any laser emission.

All the patients will follow the hospital standard management for oral mucositis.

All patients will be assessed for

1. Pain score using CHIMES,

2. Oral mucositis using NCI-CTCAE scale V5 on days, 0,4,7 and 11.

3. Measuring the duration of the lesion.

Conditions

Oral Mucositis; Childhood Acute Lymphoblastic Leukemia

Study Design

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

Study Groups

Group I

Seventeen patients will receive treatment using the red wavelength (660 nm) to provide biostimulation. Plus the current protocol (antifungal +/- antiviral and analgesics) used by CCHE which will be recorded in the patient's file.

Group Type: EXPERIMENTAL

Laser Therapy

Intervention Type: DEVICE

\- Laser will be applied with the specified wave length using a diode laser device over 4 consecutive days.

Group II

Seventeen patients will receive treatment using the infrared wavelength (970 nm) to provide biosstimulation. plus the current protocol(antifungal +/- antiviral and analgesics) used by CCHE which will be recorded in the patient's file.

Group Type: EXPERIMENTAL

Laser Therapy

Intervention Type: DEVICE

\- Laser will be applied with the specified wave length using a diode laser device over 4 consecutive days.

Group III

Seventeen patients will receive mock treatment which is the exact repetition of the treatment modality but without any laser emission plus the current protocol(antifungal +/- antiviral and analgesics) used by CCHE which will be recorded in the patient's file

Group Type: SHAM_COMPARATOR

Sham procedure

Intervention Type: DEVICE

Seventeen patients will receive mock treatment which is the exact repetition of the treatment modality but without any laser emission plus the current Protocol(antifungal +/- antiviral and analgesics) used by CCHE which will be recorded in the patient's file

Interventions

Laser Therapy

\- Laser will be applied with the specified wave length using a diode laser device over 4 consecutive days.

Intervention Type: DEVICE

Sham procedure

Seventeen patients will receive mock treatment which is the exact repetition of the treatment modality but without any laser emission plus the current Protocol(antifungal +/- antiviral and analgesics) used by CCHE which will be recorded in the patient's file

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with Acute Lymphoblastic Leukemia in the induction therapy phase and have oral mucositis grade 2 or more.

2. Age: 3-14 years old of both genders.

3. No previous treatment with laser.

4. Ability to open mouth for more than 2 cm for the duration of laser application with a level of cooperation (Frankl rating 3 or 4).

5. Patients who still have 10 days in their induction therapy phase or can be followed up for a mininum of 10 days after the development of oral mucositis

Exclusion Criteria

1. Patients receiving radiotherapy

2. Received oral Cryotherapy or IV keratinocyte growth factor for oral mucositis

3. Patients with unstable clinical condition (e.g. sepsis)

4. Patients who will be withdrawn from participation according to their request or due to loss in follow up

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 14 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

Hussein ElNoury, MSc

Role: PRINCIPAL_INVESTIGATOR

NewGiza University

Locations

Children Cancer Hospital Egypt 57357

Cairo, , Egypt

Site Status: RECRUITING

Children Cancer Hospital in Egypt 57357

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ebtesam Hanafy

Role: CONTACT

Ebtesam.Hanafy@57357.org

25351500 ext. 7209

Other Identifiers

CCHE-ALL004

Identifier Type: -

Identifier Source: org_study_id