Oral MucositisPhase 1NCT06044142
Curcumin VS Photo-bio-modulation Therapy of Oral Mucositis in Pediatric Patients Undergoing Anti-Cancer Non-invasive Treatment
A Phase 1 study testing Curcumin and Laser in people with Oral Mucositis and Pediatric Cancer, run by Riyadh Elm University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Oral Mucositis, Pediatric Cancer
- What is being tested?
- Curcumin and Laser
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Mar 2023to 30 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Patients with age less than 3 years and more than 15 years of age
- patients with systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Photodynamic Therapy by Curcumin VS Photo-bio-modulation Therapy of Oral Mucositis in Pedology Patient Undergoing Anti-Cancer Non-invasive Treatment
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.
Read the 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.
- Conditions
- Oral Mucositis, Pediatric Cancer
- Being tested
- Curcumin, Laser
- Keywords
- Curcumin, Photodynamic therapy, Pedology, Photo-bio-modulation, Oral Mucositis
- Medical subject headings
- Stomatitis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Curcumin and low laser therapy will be used on patients undergoing chemotherapy
LaserDevice
Low level laser therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Mar 2023
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tayyaba Zeeshan, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044142
- Sponsor's protocol ID
- FRP/2023/519/1030
- Status last verified
- Aug 2024
- First submitted
- 5 Sep 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy by Curcumin VS Photo-bio-modulation Therapy of Oral Mucositis in Pedology Patient Undergoing Anti-Cancer Non-invasive Treatment
- ClinicalTrials.gov ID
- NCT06044142
- Acronym / sponsor ID
- FRP/2023/519/1030
- Conditions
- Oral Mucositis, Pediatric Cancer
- Keywords
- Curcumin, Photodynamic therapy, Pedology, Photo-bio-modulation, Oral Mucositis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Oral Mucositis | Experimental | Drug: Curcumin, Device: LaserGroup 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: Oral Mucositis | Placebo comparator | Device: LaserGroup 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. |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with age less than 3 years and more than 15 years of age
- patients with systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminCurcumin and low laser therapy will be used on patients undergoing chemotherapy | Drug | Group A: Oral Mucositis |
| LaserLow level laser therapy | Device | Group A: Oral Mucositis, Group B: Oral Mucositis |
Primary outcome
Assess the impact of non-invasive photodynamic therapy by Curcumin
Time frame: 5 months
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
Time frame: 5 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Curcumin and Laser in people with Oral Mucositis and Pediatric Cancer, run by Riyadh Elm University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the impact of non-invasive photodynamic therapy by Curcumin (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.