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

NCT05452668 | Unknown DMC

• 1 other identifier: CCHE-ALL004
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

Oral Mucositis; Childhood Acute Lymphoblastic Leukemia

Keywords

Oral Mucositis; Childhood Acute Lymphoblastic Leukemia; Laser therapy; low level laser therapy

Outcome Measures

Primary Outcomes (1)

• Pain Assessment

  Assessing the change from baseline pain at day 4. Pain assessment will be done by Children's International Mucositis Evaluation Scale (ChIMES). For children less than 8 years the guardian will assist the child in filling the chart. Pain will be measured on day 0, 4, 7 and 11

  4 days

Secondary Outcomes (1)

• Oral Mucositis Severity:

  4 days

Study Arms (3)

Group I

EXPERIMENTAL

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.

Device: Laser Therapy

Group II

EXPERIMENTAL

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.

Device: Laser Therapy

Group III

SHAM COMPARATOR

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

Device: Sham procedure

Interventions

Laser Therapy DEVICE

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

Group I; Group II

Sham procedure 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

Group III

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with Acute Lymphoblastic Leukemia in the induction therapy phase and have oral mucositis grade 2 or more.
• Age: 3-14 years old of both genders.
• No previous treatment with laser.
• 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).
• 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

You may not qualify if:

• Patients receiving radiotherapy
• Received oral Cryotherapy or IV keratinocyte growth factor for oral mucositis
• Patients with unstable clinical condition (e.g. sepsis)
• Patients who will be withdrawn from participation according to their request or due to loss in follow up

Sponsors & Collaborators

• Children's Cancer Hospital Egypt 57357: lead

Study Sites (2)

Children Cancer Hospital Egypt 57357

Cairo, Egypt

RECRUITING

Children Cancer Hospital in Egypt 57357

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Stomatitis; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Hussein ElNoury, MSc

  NewGiza University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ebtesam Hanafy

CONTACT

25351500; Ebtesam.Hanafy@57357.org

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: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 11, 2022
• Study Start: May 16, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: August 21, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)