NCT05400031

Oral Care With Propolis in Pediatric Oncology Patients

Does Oral Care With Propolis Affect the Development of Oral Mucositis in Pediatric Oncology Patients: A Randomized Controlled Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Izmir Katip Celebi University · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Mucositis

Interventions

Type	Name	Description
BIOLOGICAL	propolis	After obtaining written consent, oral identification of all participants will be performed prior to randomization. Oral diagnosis of children receiving chemotherapy will be repeated on day 0, day 5, and day 10, and the difference between the Oral Mucositis Rating Scale mean scores of the children in the groups will be examined. Oral Mucositis Assessment: Oral Mucositis Rating Scale will be used. The oral mucosa of children will be evaluated using the World Health Organization Oral Mucositis Classification.
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-05-01
• Completion: 2023-06-01
• First posted: 2022-06-01
• Last updated: 2023-09-29

Locations

1 site across 1 country: Turkey (Türkiye)