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

Primary Purpose

Oral Mucositis, Childhood Acute Lymphoblastic Leukemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser Therapy
Sham procedure
Sponsored by
Children's Cancer Hospital Egypt 57357
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Mucositis focused on measuring Oral Mucositis, Childhood Acute Lymphoblastic Leukemia, Laser therapy, low level laser therapy

Eligibility Criteria

3 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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 Patients who will be withdrawn from participation according to their request or due to loss in follow up

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    Group I

    Group II

    Group III

    Arm Description

    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.

    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.

    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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Oral Mucositis Severity:
    Assessing the change in the Oral Mucositis Severity from baseline at day 4. his will be measured using the National Cancer Institute Common Toxicity Criteria for adverse events (NCI-CTCAE) scale version 5

    Full Information

    First Posted
    July 5, 2022
    Last Updated
    November 27, 2022
    Sponsor
    Children's Cancer Hospital Egypt 57357
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05452668
    Brief Title
    Laser Therapy Effect on Oral Mucositis in Childhood Acute Lymphoblastic Leukemia Patients
    Official Title
    Effectiveness of Laser Therapy of Different Wavelengths in Chemotherapy Induced Oral Mucositis in Children With Acute Lymphoblastic Leukemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 20, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Children's Cancer Hospital Egypt 57357

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 Pain score using CHIMES, Oral mucositis using NCI-CTCAE scale V5 on days, 0,4,7 and 11. Measuring the duration of the lesion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Mucositis, Childhood Acute Lymphoblastic Leukemia
    Keywords
    Oral Mucositis, Childhood Acute Lymphoblastic Leukemia, Laser therapy, low level laser therapy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    The outcome evaluator will be a single personnel from the oncology team following up with the case.
    Allocation
    Randomized
    Enrollment
    51 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Group II
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Group III
    Arm Type
    Sham Comparator
    Arm Description
    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
    Intervention Name(s)
    Laser Therapy
    Intervention Description
    - Laser will be applied with the specified wave length using a diode laser device over 4 consecutive days.
    Intervention Type
    Device
    Intervention Name(s)
    Sham procedure
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Pain Assessment
    Description
    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
    Time Frame
    4 days
    Secondary Outcome Measure Information:
    Title
    Oral Mucositis Severity:
    Description
    Assessing the change in the Oral Mucositis Severity from baseline at day 4. his will be measured using the National Cancer Institute Common Toxicity Criteria for adverse events (NCI-CTCAE) scale version 5
    Time Frame
    4 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ebtesam Hanafy
    Phone
    25351500
    Ext
    7209
    Email
    Ebtesam.Hanafy@57357.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hussein ElNoury, MSc
    Organizational Affiliation
    New Giza University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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