Oral Care With Propolis in Pediatric Oncology Patients

Not Applicable

Completed

• Conditions: Oral Mucositis
• Interventions: Biological: Placebo; Biological: propolis

• Registration Number: NCT05400031
• Lead Sponsor: Izmir Katip Celebi University

Brief Summary

According to the data from the World Health Organization, approximately 14 million people are diagnosed with cancer every year, and this number is expected to increase further in the next 10 years. Multidisciplinary treatment consisting of chemotherapy, radiotherapy and surgery is applied in childhood cancers. In chemotherapy, the target is cancerous cells, but high doses of chemotherapeutic agents do not have selectivity. Intact tissue cells are also affected by this cytotoxicity. Mucositis develops in the patient, especially as a result of the mucosal cells being affected. Mucositis is defined as damage to the mucosa lining the oral cavity, pharynx, larynx, oesophagus and gastrointestinal tract due to cancer treatment. It is one of the most important side effects of both chemotherapy and radiotherapy. This study is carried out to determine the effectiveness of propolis in preventing the formation of oral mucositis due to multiple use of chemotherapeutic drugs.

Detailed Description

According to the data from the World Health Organization, approximately 14 million people are diagnosed with cancer every year, and this number is expected to increase further in the next 10 years. Multidisciplinary treatment consisting of chemotherapy, radiotherapy and surgery is applied in childhood cancers. In chemotherapy, the target is cancerous cells, but high doses of chemotherapeutic agents do not have selectivity. Intact tissue cells are also affected by this cytotoxicity. Mucositis develops in the patient, especially as a result of the mucosal cells being affected. Mucositis is defined as damage to the mucosa lining the oral cavity, pharynx, larynx, oesophagus and gastrointestinal tract due to cancer treatment. It is one of the most important side effects of both chemotherapy and radiotherapy. This study is carried out to determine the effectiveness of propolis in preventing the formation of oral mucositis due to multiple uses of chemotherapeutic drugs.

Study Timeline

• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-31
• Study Start: 2022-06-01
• Study First Posted: 2022-06-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-06-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Volunteering to participate in the study
• Receiving chemotherapy treatment for lymphoproliferative malignant disease (leukaemia, lymphoma) or other childhood solid tumour (such as central nervous system tumour, neuroblastoma, osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, hepatoblastoma, germ cell tumours)
• Being between the ages of 2-18 (Although there is no harm in using propolis, it is inconvenient for children under the age of 2 to use honey and its by-products due to botulism)
• No development of oral mucositis
• The child who does not smoke

Exclusion Criteria

• The patient does not receive head and neck RT (increases the incidence of oral mucositis by 40%).
• The patient is allergic to bee products.
• Exclusion Criteria and Practices in this Case:
• Development of an allergic reaction to propolis (Applied oral care protocol is stopped, removed from the sample)
• Starting RT
• The child's need for MV support

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo	In this group, the researcher will provide the participants with a propolis vehicle
propolis group	propolis	In this group, the researcher will provide the participants with a propolis solution.

Primary Outcome Measures

Name	Time	Method
Oral mucositis grading	tenth day of the intervention	Oral Mucositis Assessment Scale is a classification method accepted by the World Health Organization and used all over the world. It has standard clauses that will be interpreted in the same way by all people. However, in order to ignore the differences in interpretation, multi-research evaluation will be used in the first 20 observations and the consistency between the observers will be analyzed with Kappa analysis and the follow-ups will continue.

Trial Locations

Locations (1)

Tepecik Research and Training Hospital; 🇹🇷 İzmir, Turkey