Propolis for Management of Chemotherapy-Induced Oral Mucositis in Pediatric Patients

Not Applicable

Not yet recruiting

• Conditions: Oral Mucositis Due to Chemotherapy
• Interventions: Drug: propolis; Drug: chlorohexidine mouthwash and topical antifungal

• Registration Number: NCT07073092
• Lead Sponsor: Ain Shams University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study Start: 2025-07-15
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Primary Completion: 2025-12-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	propolis	propolis medicated jelly candy+ standard oral care (chlorohexidine and topical anti-fungal) three times daily for 21 days
study group	chlorohexidine mouthwash and topical antifungal	propolis medicated jelly candy+ standard oral care (chlorohexidine and topical anti-fungal) three times daily for 21 days
control group	chlorohexidine mouthwash and topical antifungal	Standard oral care (chlorohexidine mouth wash and topical anti-fungal) three times daily for 21 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

faculty of dentistry Ain shams university; 🇪🇬 Cairo, Egypt