Oral Care With Propolis in Pediatric Oncology Patients

Izmir Katip Celebi University

Status: Completed

Conditions: Oral Mucositis

Treatments: Biological: Placebo; Biological: propolis

Study type: Interventional

Funder types: Other

Identifiers

NCT05400031

2022/61

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 3 patient groups, including a placebo group

Control

No Intervention group

Description:

In this group, the researcher will provide the participants with routine care.

placebo group

Placebo Comparator group

Description:

In this group, the researcher will provide the participants with a propolis vehicle

Treatment:

Biological: Placebo

propolis group

Active Comparator group

Description:

In this group, the researcher will provide the participants with a propolis solution.

Treatment:

Biological: propolis