search
Back to results

Curcumin VS Photo-bio-modulation Therapy of Oral Mucositis in Pediatric Patients Undergoing Anti-Cancer Non-invasive Treatment

Primary Purpose

Oral Mucositis, Pediatric Cancer

Status
Recruiting
Phase
Phase 1
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Curcumin
Laser
Sponsored by
Riyadh Elm University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Mucositis focused on measuring Curcumin, Photodynamic therapy, Pedology, Photo-bio-modulation, Oral Mucositis

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients in age group of 3 years to 15 years mucositis (categorized >1) based on the guidelines of WHO Toxicity Criteria must be able to open the mouth properly Exclusion Criteria: Patients with age less than 3 years and more than 15 years of age patients with systemic diseases

Sites / Locations

  • Riyadh Elm UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A: Oral Mucositis

Group B: Oral Mucositis

Arm Description

Group A will be submitted to photodynamic therapy (Curcumin and red laser, λ450 nm) with 142 J/cm2, 100mW. The number of points will be calculated based on the size of lesion (1 laser shot per cm2 of lesion). The intervention will be repeated daily until cure of the oral mucositis was attained.

Group B (control group) will be submitted to low level (LL) laser therapy (λ660 nm) with 1J energy per point at 100mW power output for 10 seconds on daily basis until the lesion is clinically cured. The light will be applied perpendicular to the lesion on a continuous mode. The number of points will be calculated similarly as mentioned for patients included in Group A.

Outcomes

Primary Outcome Measures

Assess the impact of non-invasive photodynamic therapy by Curcumin
The scale proposed and accepted by World Health Organization (WHO) will be used to categorize the changes in oral mucositis condition evaluated over time in four different categories: i) Category 0 = Absence of change in condition; ii) Category I = Persistence of erythematous condition and failure to have solid food; iii) Category II = Persistence of erythematous condition with solid dietary food intake iv) Category III: Presence of painful erythematous lesion with liquids as a dietary intake; and Category IV: patient with special mode for dietary intake (parenteral or enteral). For evaluating the intensity of paint and variation in function, the ChIME scale will be used. The data will be recorded on special designed forms.
Assess the impact of photo-bio-modulation low level (LL) laser treatment in managing mucositis
The scale proposed and accepted by World Health Organization (WHO) will be used to categorize the changes in oral mucositis condition evaluated over time in four different categories: i) Category 0 = Absence of change in condition; ii) Category I = Persistence of erythematous condition and failure to have solid food; iii) Category II = Persistence of erythematous condition with solid dietary food intake iv) Category III: Presence of painful erythematous lesion with liquids as a dietary intake; and Category IV: patient with special mode for dietary intake (parenteral or enteral). For evaluating the intensity of paint and variation in function, the ChIME scale will be used. The data will be recorded on special designed forms.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2023
Last Updated
October 8, 2023
Sponsor
Riyadh Elm University
Collaborators
Tayyaba Zeeshan
search

1. Study Identification

Unique Protocol Identification Number
NCT06044142
Brief Title
Curcumin VS Photo-bio-modulation Therapy of Oral Mucositis in Pediatric Patients Undergoing Anti-Cancer Non-invasive Treatment
Official Title
Photodynamic Therapy by Curcumin VS Photo-bio-modulation Therapy of Oral Mucositis in Pedology Patient Undergoing Anti-Cancer Non-invasive Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riyadh Elm University
Collaborators
Tayyaba Zeeshan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The main objective of this study is to assess the impact of non-invasive photodynamic therapy by Curcumin and photo-bio-modulation low level (LL) laser treatment in managing mucositis induced by chemotherapy in pediatric patients. A randomized clinical trial will be conducted involving 90 patients aged between 3 years and 15 years. The trial will be open, controlled, and blinded, and the patients will be divided into two groups.
Detailed Description
The study will be designed based on the Consolidated Standards of Reporting Trials (CONSORT) and conducted on approval from the Ethics Committee of the University. It will be a randomized controlled trial conducted among 90 pediatric patients of 3 years to 15 years age group. The inclusion criterion for the study will be i) patients in age group of 3 years to 15 years and ii) mucositis (categorized >1) based on the guidelines of WHO Toxicity Criteria. Pediatric patients having a malignant type of neoplasm and/or clinically evident oral microbial disease and/or with serious medical issues will be excluded from the study. The oral mucositis will be diagnosed by a dentist available at the site of tertiary care hospital for chemotherapy. The potential participant will be referred to the research group for inclusion in the study based on the defined inclusion criterion. The procedure of research will be explained to the guardians of the participants. On acceptance, the guardians will be requested to sign the informed consent form. The patients will considered as a new case for intervention on commencement of each chemo-therapy cycle. The patients will again added to a new randomized controlled trial if encountered an episode of oral mucositis. Intervention for Photodynamic and Laser Therapy Prior to intervention of laser and photodynamic therapy the patients will be educated and instructed to maintain oral hygiene during cancer treatments. The instructions included brushing teeth with adequate amount of toothpaste and record it on follow-up chart. Later on inspection by the research team, if a patient is diagnosed with any carious lesion, retained root or gingival infection associated with dental plaque will be categorized as excluded from study. The procedure will be performed at beside for the patients admitted in the hospital; whereas outpatients will be seated on dental chairs of outpatient clinics. An open controlled and blind, randomized clinical trial will be conducted with 45 patients, from 3 years to 15 years old, who will be divided into two groups. Group A will be submitted to photodynamic therapy (Curcumin and red laser, λ450 nm) with 142 J/cm2, 100mW. The number of points will be calculated based on the size of lesion (1 laser shot per cm2 of lesion). The intervention will be repeated daily until cure of the oral mucositis was attained. The clinical cure will be categorized as restoring the normal physiological functions such as chewing, swallowing and phonation without any symptoms of pain; additionally signs of tissue regeneration are evident. Group B (control group) will be submitted to low level (LL) laser therapy (λ660 nm) with 1J energy per point at 100mW power output for 10 seconds on daily basis until the lesion was clinically cured. The light will be applied perpendicular to the lesion on a continuous mode. The number of points will calculated similarly as mentioned for patients included in Group A. Oral Mucositis Evaluation After inter-examiner reliability test, the patients will be evaluated by the by the research group. The scale proposed and accepted by World Health Organization (WHO) will be used to categorize the changes in oral mucositis condition evaluated over time in four different categories: i) Category 0 = Absence of change in condition; ii) Category I = Persistence of erythematous condition and failure to have solid food; iii) Category II = Persistence of erythematous condition with solid dietary food intake iv) Category III: Presence of painful erythematous lesion with liquids as a dietary intake; and Category IV: patient with special mode for dietary intake (parenteral or enteral). For evaluating the intensity of paint and variation in function, the ChIME scale will be used. The data will be recorded on special designed forms. The patients will be divided randomly and later treated with lasers and photodynamic therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis, Pediatric Cancer
Keywords
Curcumin, Photodynamic therapy, Pedology, Photo-bio-modulation, Oral Mucositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Oral Mucositis
Arm Type
Experimental
Arm Description
Group A will be submitted to photodynamic therapy (Curcumin and red laser, λ450 nm) with 142 J/cm2, 100mW. The number of points will be calculated based on the size of lesion (1 laser shot per cm2 of lesion). The intervention will be repeated daily until cure of the oral mucositis was attained.
Arm Title
Group B: Oral Mucositis
Arm Type
Placebo Comparator
Arm Description
Group B (control group) will be submitted to low level (LL) laser therapy (λ660 nm) with 1J energy per point at 100mW power output for 10 seconds on daily basis until the lesion is clinically cured. The light will be applied perpendicular to the lesion on a continuous mode. The number of points will be calculated similarly as mentioned for patients included in Group A.
Intervention Type
Drug
Intervention Name(s)
Curcumin
Intervention Description
Curcumin and low laser therapy will be used on patients undergoing chemotherapy
Intervention Type
Device
Intervention Name(s)
Laser
Intervention Description
Low level laser therapy
Primary Outcome Measure Information:
Title
Assess the impact of non-invasive photodynamic therapy by Curcumin
Description
The scale proposed and accepted by World Health Organization (WHO) will be used to categorize the changes in oral mucositis condition evaluated over time in four different categories: i) Category 0 = Absence of change in condition; ii) Category I = Persistence of erythematous condition and failure to have solid food; iii) Category II = Persistence of erythematous condition with solid dietary food intake iv) Category III: Presence of painful erythematous lesion with liquids as a dietary intake; and Category IV: patient with special mode for dietary intake (parenteral or enteral). For evaluating the intensity of paint and variation in function, the ChIME scale will be used. The data will be recorded on special designed forms.
Time Frame
5 months
Title
Assess the impact of photo-bio-modulation low level (LL) laser treatment in managing mucositis
Description
The scale proposed and accepted by World Health Organization (WHO) will be used to categorize the changes in oral mucositis condition evaluated over time in four different categories: i) Category 0 = Absence of change in condition; ii) Category I = Persistence of erythematous condition and failure to have solid food; iii) Category II = Persistence of erythematous condition with solid dietary food intake iv) Category III: Presence of painful erythematous lesion with liquids as a dietary intake; and Category IV: patient with special mode for dietary intake (parenteral or enteral). For evaluating the intensity of paint and variation in function, the ChIME scale will be used. The data will be recorded on special designed forms.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients in age group of 3 years to 15 years mucositis (categorized >1) based on the guidelines of WHO Toxicity Criteria must be able to open the mouth properly Exclusion Criteria: Patients with age less than 3 years and more than 15 years of age patients with systemic diseases
Facility Information:
Facility Name
Riyadh Elm University
City
Riyadh
State/Province
Ar Riyadh
ZIP/Postal Code
1331
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeeshan Qamar, BDS, MSc, PhD
Phone
00966112481222
Ext
259
Email
zeeshan.qamar@riyadh.edu.sa

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Curcumin VS Photo-bio-modulation Therapy of Oral Mucositis in Pediatric Patients Undergoing Anti-Cancer Non-invasive Treatment

We'll reach out to this number within 24 hrs