Clinical trial · Interventional
Curcumin VS Photo-bio-modulation Therapy of Oral Mucositis in Pediatric Patients Undergoing Anti-Cancer Non-invasive Treatment
Photodynamic Therapy by Curcumin VS Photo-bio-modulation Therapy of Oral Mucositis in Pedology Patient Undergoing Anti-Cancer Non-invasive Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Curcumin | Drug | — | UNRESOLVED |
| Laser | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A: Oral Mucositis
- 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.
- interventionNames
- Drug: Curcumin
- Device: Laser
- type
- PLACEBO_COMPARATOR
- label
- Group B: Oral Mucositis
- 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.
- interventionNames
- Device: Laser
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 15 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available