Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Photodynamic Therapy by Curcumin VS Photo-bio-modulation Therapy of Oral Mucositis in Pedology Patient Undergoing Anti-Cancer Non-invasive Treatment

ID
Name
FRP/2023/519/1030
Description
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.
Trial arms
Trial start
2023-03-15
Estimated PCD
2023-12-01
Trial end
2024-01-01
Status
Recruiting
Phase
Early phase I
Treatment
Curcumin
Curcumin and low laser therapy will be used on patients undergoing chemotherapy
Arms:
Group A: Oral Mucositis
Laser
Low level laser therapy
Arms:
Group A: Oral Mucositis, Group B: Oral Mucositis
Size
90
Primary endpoint
Assess the impact of non-invasive photodynamic therapy by Curcumin
5 months
Assess the impact of photo-bio-modulation low level (LL) laser treatment in managing mucositis
5 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2023-10-27

1 organization

1 product

2 indications

Organization
Riyadh Elm University
Product
Curcumin
Indication
Oral Mucositis
Indication
Pediatric Cancer