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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-18
SponsorAin Shams University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children of both genders less than 18 years receiving intensive chemotherapy.

Taking intensified chemotherapy

A healthy oral mucosa.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • propolis

    Drug

    propolis medicated jelly candy.

  • chlorohexidine mouthwash and topical antifungal

    Drug

    chlorohexidine mouthwash and topical antifungal

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: study groupExperimental treatment 2 interventions
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

oral mucositis score (WHO)

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.

Time frame
3 weeks

Secondary outcomes

1

pain (VAS)

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"

Time frame
3 weeks
2

body mass index

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).

Time frame
3 weeks
3

Pediatric Quality of Life

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.

Time frame
3 weeks
4

Total anti-oxidant assay

Assess the effectiveness of propolis on total antioxidant assay in pediatric patients undergoing chemotherapy using biochemical analysis

Time frame
3 weeks

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: