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

NCT06044142 | Completed Phase 1

• 1 other identifier: FRP/2023/519/1030
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis; Pediatric Cancer

Keywords

Curcumin; Photodynamic therapy; Pedology; Photo-bio-modulation; Oral Mucositis

Outcome Measures

Primary Outcomes (2)

• 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.

  5 months

• 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.

  5 months

Study Arms (2)

Group A: Oral Mucositis

EXPERIMENTAL

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.

Drug: Curcumin; Device: Laser

Group B: Oral Mucositis

PLACEBO COMPARATOR

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.

Device: Laser

Interventions

Curcumin DRUG

Curcumin and low laser therapy will be used on patients undergoing chemotherapy

Group A: Oral Mucositis

Laser DEVICE

Low level laser therapy

Group A: Oral Mucositis; Group B: Oral Mucositis

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patients with age less than 3 years and more than 15 years of age
• patients with systemic diseases

Sponsors & Collaborators

• Riyadh Elm University: lead

Study Sites (1)

Riyadh Elm University

Riyadh, Ar Riyadh, 1331, Saudi Arabia

Location

MeSH Terms

Conditions

Stomatitis; Neoplasms

Interventions

Curcumin; Lasers

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director of Oral Diagnosis Postgraduate Program

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 21, 2023
• Study Start: March 15, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 30, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

SA (1)