Propolis for Management of Chemotherapy-Induced Oral Mucositis in Pediatric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: propolis, chlorohexidine mouthwash and topical antifungal.
- Who it may be relevant to
- Registry conditions: Oral Mucositis Due to Chemotherapy. Basic parameters: 2 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Propolis for Management of Chemotherapy-Induced Oral Mucositis in Pediatric Patients: A Randomized Controlled Clinical Trial With Biochemical Analysis
Overview
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
Interventions
- Drug propolis
propolis medicated jelly candy. - Drug chlorohexidine mouthwash and topical antifungal
chlorohexidine mouthwash and topical antifungal
Primary outcome measures
- oral mucositis score (WHO) [Time frame: 3 weeks]
Secondary outcome measures (4)
- pain (VAS) [Time frame: 3 weeks]
- body mass index [Time frame: 3 weeks]
- Pediatric Quality of Life [Time frame: 3 weeks]
- Total anti-oxidant assay [Time frame: 3 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- faculty of dentistry Ain shams university — Cairo
Publications
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07073092 · FDASU-Rec IR/D052520