Clinical trial NCT05400031: Oral Care With Propolis in Pediatric Oncology Patients
Official title: Does Oral Care With Propolis Affect the Development of Oral Mucositis in Pediatric Oncology Patients: A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
Collaborators: name: Tepecik Training and Research Hospital
First posted: 2022-06-01
Enrollment: 108
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oral mucositis grading
timeFrame: first day of the intervention
measure: Oral mucositis grading
timeFrame: fifth day of the intervention
measure: Oral mucositis grading
timeFrame: tenth day of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Tepecik Research and Training Hospital
Study officials:
affiliation: Tepecik Research and Training Hospital
name: ZUHAL ONER SIVIS, MD
role: STUDY_CHAIR
References: