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

NCT07073092 | Not Yet Recruiting Phase 2

• 1 other identifier: FDASU-Rec IR/D052520
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Mucositis Due to Chemotherapy

Outcome Measures

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.

  3 weeks

Secondary Outcomes (4)

• pain (VAS)

  3 weeks

• body mass index

  3 weeks

• Pediatric Quality of Life

  3 weeks

• Total anti-oxidant assay

  3 weeks

Study Arms (2)

study group

EXPERIMENTAL

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

Drug: propolis; Drug: chlorohexidine mouthwash and topical antifungal

control group

ACTIVE COMPARATOR

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

Drug: chlorohexidine mouthwash and topical antifungal

Interventions

propolis DRUG

propolis medicated jelly candy.

study group

chlorohexidine mouthwash and topical antifungal DRUG

chlorohexidine mouthwash and topical antifungal

control group; study group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of dentistry Ain shams university

Cairo, Egypt

Location

Related Publications (6)

• Docimo R, Anastasio MD, Bensi C. Chemotherapy-induced oral mucositis in children and adolescents: a systematic review. Eur Arch Paediatr Dent. 2022 Aug;23(4):501-511. doi: 10.1007/s40368-022-00727-5. Epub 2022 Jul 2.

  PMID: 35779225 BACKGROUND

• Keys A, Fidanza F, Karvonen MJ, Kimura N, Taylor HL. Indices of relative weight and obesity. Int J Epidemiol. 2014 Jun;43(3):655-65. doi: 10.1093/ije/dyu058. Epub 2014 Apr 1.

  PMID: 24691951 BACKGROUND

• Villa A, Vollemans M, De Moraes A, Sonis S. Concordance of the WHO, RTOG, and CTCAE v4.0 grading scales for the evaluation of oral mucositis associated with chemoradiation therapy for the treatment of oral and oropharyngeal cancers. Support Care Cancer. 2021 Oct;29(10):6061-6068. doi: 10.1007/s00520-021-06177-x. Epub 2021 Mar 31.

  PMID: 33788003 BACKGROUND

• Gomaa E, Ayoub MM. Vardenafil oral jellies as a potential approach for management of pediatric irritable bowel syndrome. Saudi Pharm J. 2021 Sep;29(9):955-962. doi: 10.1016/j.jsps.2021.07.020. Epub 2021 Jul 27.

  PMID: 34588841 BACKGROUND

• Dastan F, Ameri A, Dodge S, Hamidi Shishvan H, Pirsalehi A, Abbasinazari M. Efficacy and safety of propolis mouthwash in management of radiotherapy induced oral mucositis; A randomized, double blind clinical trial. Rep Pract Oncol Radiother. 2020 Nov-Dec;25(6):969-973. doi: 10.1016/j.rpor.2020.09.012. Epub 2020 Oct 3.

  PMID: 33100913 BACKGROUND

• Ibrahim SS, Hassanein FEA, Zaky HW, Gamal H. Clinical and biochemical assessment of the effect of glutamine in management of radiation induced oral mucositis in patients with head and neck cancer: Randomized controlled clinical trial. J Stomatol Oral Maxillofac Surg. 2024 Jun;125(3S):101827. doi: 10.1016/j.jormas.2024.101827. Epub 2024 Mar 15.

  PMID: 38493953 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Propolis; Antifungal Agents

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Dina B. Elkhouly

CONTACT

+201063147477; dinaborham@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: July 15, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)