Oral Care With Propolis in Pediatric Oncology Patients

NCT05400031 | Completed

• 1 other identifier: 2022/61
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Control

NO INTERVENTION

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

placebo group

PLACEBO COMPARATOR

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

Biological: Placebo

propolis group

ACTIVE COMPARATOR

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

Biological: propolis

Interventions

propolis BIOLOGICAL

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.

propolis group

Placebo BIOLOGICAL

Placebo

placebo group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• The patient does not receive head and neck RT (increases the incidence of oral mucositis by 40%).
• The patient is allergic to bee products.
• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead
• Tepecik Training and Research Hospital: collaborator

Study Sites (1)

Tepecik Research and Training Hospital

Izmir, 35640, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stomatitis

Interventions

Propolis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• ZUHAL ONER SIVIS, MD

  Tepecik Research and Training Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: June 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)