Oral Mucositis Due to Chemotherapy
Conditions
Brief summary
The goal of this clinical trial is to evaluate the efficacy of propolis in the prevention of oral mucositis and reducing pain score in children undergoing chemotherapy, and assessing its impact on body mass index, pediatric quality of life and total antioxidant assay. The main question it aims to answer is: What is the effect of propolis on oral mucositis scores in children undergoing chemotherapy? Participants will: Take propolis 3 times daily for 21 days follow up weekly for 3 weeks
Interventions
DRUGpropolis
propolis medicated jelly candy.
DRUGchlorohexidine mouthwash and topical antifungal
chlorohexidine mouthwash and topical antifungal
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Children of both genders less than 18 years receiving intensive chemotherapy. * Oncology patients receiving intensified chemotherapy at Oncology unit, Children's Hospital, Ain Shams University, Egypt, who meet the following criteria: * Taking intensified chemotherapy * A healthy oral mucosa.
Exclusion criteria
* Allergy to bee products. * Severe systemic illness unrelated to cancer (Diabetes, Hypertension, …) * Inability to take oral medication or unwillingness to participate in the study * Radiotherapy in the head and neck area. * Malignant or potentially malignant lesions of the oral cavity. * Undergoing any other procedures to prevent oral mucositis except standard oral care. * Patients are unable to commit to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| oral mucositis score (WHO) | 3 weeks | Assess the effectiveness of propolis in treatment of chemotherapy induced oral mucositis in pediatric cancer patients using the WHO Scale (WHO), scoring from 0 to 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain (VAS) | 3 weeks | Assess the effectiveness of propolis on pain levels. Pain will be assessed by (visual analogue scale). The P-VAS evaluation ranges from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain |
| body mass index | 3 weeks | Assess the effectiveness of propolis on BMI in pediatric patients undergoing chemotherapy. Body mass index (BMI, kg/m2) was defined as the body mass (kg) divided by the square of the body height (m). |
| Pediatric Quality of Life | 3 weeks | Assess the effectiveness of propolis on Pediatric Quality of Life using the Arabic validated version of Peds QL™ Inventory both Child Self Report and Parent Proxy Report. 0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Often, 4 = Almost Always Scoring Method: 1\. Reverse Scoring System: 0 = 100 points, 1 = 75 points, 2 = 50 points, 3 = 25 points, 4 = 0 points 2. Domain Score Calculation: Sum all question scores within a domain and divide by the number of questions in that domain. 3\. Total PedsQL Score Calculation: Sum all domain scores and divide by the total number of questions. Higher scores indicate better quality of life. |
| Total anti-oxidant assay | 3 weeks | Assess the effectiveness of propolis on total antioxidant assay in pediatric patients undergoing chemotherapy using biochemical analysis |
Countries
Egypt
Contacts
Primary ContactDina B. Elkhouly
Outcome results
None listed