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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-01-30

Brief Summary

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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

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Detailed Description

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Conditions

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Oral Mucositis Due to Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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study group

propolis medicated jelly candy+ standard oral care (chlorohexidine and topical anti-fungal) three times daily for 21 days

Group Type EXPERIMENTAL

propolis

Intervention Type DRUG

propolis medicated jelly candy.

chlorohexidine mouthwash and topical antifungal

Intervention Type DRUG

chlorohexidine mouthwash and topical antifungal

control group

Standard oral care (chlorohexidine mouth wash and topical anti-fungal) three times daily for 21 days

Group Type ACTIVE_COMPARATOR

chlorohexidine mouthwash and topical antifungal

Intervention Type DRUG

chlorohexidine mouthwash and topical antifungal

Interventions

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propolis

propolis medicated jelly candy.

Intervention Type DRUG

chlorohexidine mouthwash and topical antifungal

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes