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Effectiveness of Photo-biomodulation in the Treatment of Chemotherapy Induced Mucositis

Primary Purpose

Mucositis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Simpler diode laser
Conventional symptomatic treatment
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucositis focused on measuring mucositis - leukemia - chemotherapy

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children diagnosed with mucositis and receiving chemotherapy

Exclusion Criteria:

  • diabetes
  • trismus

Sites / Locations

  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser irradiation (Test group)

Conventional treatment (Control group

Arm Description

laser irradiation over lesion

Outcomes

Primary Outcome Measures

Self-reported pain level
Participants were asked to report the degree of pain. This was assessed using the visual analogue scale (VAS) which ranges from zero (lowest score) to 10 (highest score). Higher scores indicate higher pain level.
Oral mucositis lesion size
This was assessed using the World Health Organization oral mucositis lesion score Grade 0: no oral mucositis. Grade1: Presence of soreness and erythema. Grade 2: Presence of painful erythema and ulcerations that do not affect the patient solid food intake. Grade3: Confluent ulceration that affect the solid food intake and require liquid diet. Grade 4: The patient requires parenteral nutrition.

Secondary Outcome Measures

Full Information

First Posted
December 20, 2021
Last Updated
December 20, 2021
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05181943
Brief Title
Effectiveness of Photo-biomodulation in the Treatment of Chemotherapy Induced Mucositis
Official Title
EFFECTIVNESS OF PHOTO BIO-MODULATION IN THE TREATMENT OF CHEMOTHERAPY INDUCED ORAL MUCOSITIS IN CHILDREN WITH ACUTE LEUKEMIA Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

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

5. Study Description

Brief Summary
The aim of the current study was to study the effect of diode laser in the treatment of chemotherapy induced mucositis in young patients suffering from leukemia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis
Keywords
mucositis - leukemia - chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser irradiation (Test group)
Arm Type
Experimental
Arm Description
laser irradiation over lesion
Arm Title
Conventional treatment (Control group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Simpler diode laser
Intervention Description
Non-contacting irradiation for 30 seconds on three intraoral sites repeated four times
Intervention Type
Drug
Intervention Name(s)
Conventional symptomatic treatment
Intervention Description
Conventional treatment using oracure, BBC spray, miconaz three times daily
Primary Outcome Measure Information:
Title
Self-reported pain level
Description
Participants were asked to report the degree of pain. This was assessed using the visual analogue scale (VAS) which ranges from zero (lowest score) to 10 (highest score). Higher scores indicate higher pain level.
Time Frame
up to 2 weeks
Title
Oral mucositis lesion size
Description
This was assessed using the World Health Organization oral mucositis lesion score Grade 0: no oral mucositis. Grade1: Presence of soreness and erythema. Grade 2: Presence of painful erythema and ulcerations that do not affect the patient solid food intake. Grade3: Confluent ulceration that affect the solid food intake and require liquid diet. Grade 4: The patient requires parenteral nutrition.
Time Frame
up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children diagnosed with mucositis and receiving chemotherapy Exclusion Criteria: diabetes trismus
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21527
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Photo-biomodulation in the Treatment of Chemotherapy Induced Mucositis

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