Oral Care With Propolis in Pediatric Oncology Patients

Oral Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05400031
• Other study ID #: 2022/61
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2023
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

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.
• Placebo
Placebo

Locations

Country	Name	City	State
Turkey	Tepecik Research and Training Hospital	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Katip Celebi University	Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral mucositis grading	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.	first day of the intervention
Primary	Oral mucositis grading	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.	fifth day of the intervention
Primary	Oral mucositis grading	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.	tenth day of the intervention