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NCT Number: NCT07073092

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

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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Key information

Conditions

Oral Mucositis Due to Chemotherapy

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propolis

Drug

propolis medicated jelly candy.

chlorohexidine mouthwash and topical antifungal

Drug

chlorohexidine mouthwash and topical antifungal

Primary outcomes

  1. oral mucositis score (WHO)

    Time frame: 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 outcomes

  1. pain (VAS)

    Time frame: 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"

  2. body mass index

    Time frame: 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).

  3. Pediatric Quality of Life

    Time frame: 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:

    • 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.
    • Total PedsQL Score Calculation: Sum all domain scores and divide by the total number of questions. Higher scores indicate better quality of life.

  4. Total anti-oxidant assay

    Time frame: 3 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Dina B. Elkhouly

CONTACT

[email protected]

+201063147477

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Propolis for Management of Chemotherapy-Induced Oral Mucositis in Pediatric Patients: A Randomized Controlled Clinical Trial With Biochemical Analysis

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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