drugset / Trial / NCT07073092
Propolis for Management of Chemotherapy-Induced Oral Mucositis in Pediatric Patients
RandomizedParallel-groupSingle-blindPrevention
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
Timeline
- Start
- 2025-07-15
- Primary completion
- 2025-12-30
- Completion
- 2026-01-30
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PROPOLIS WAX | Traditional medicine (herbal / TCM) | — | — |
| Background | Chlorohexidine | Unknown | — | Other |