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Oral Care With Propolis in Pediatric Oncology Patients

Primary Purpose

Oral Mucositis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
propolis
Placebo
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Tepecik Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Placebo Comparator

Active Comparator

Arm Label

Control

placebo group

propolis group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 26, 2022
Last Updated
September 28, 2023
Sponsor
Izmir Katip Celebi University
Collaborators
Tepecik Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05400031
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University
Collaborators
Tepecik Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
In this group, the researcher will provide the participants with routine care.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
In this group, the researcher will provide the participants with a propolis vehicle
Arm Title
propolis group
Arm Type
Active Comparator
Arm Description
In this group, the researcher will provide the participants with a propolis solution.
Intervention Type
Biological
Intervention Name(s)
propolis
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Oral mucositis grading
Description
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.
Time Frame
first day of the intervention
Title
Oral mucositis grading
Description
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.
Time Frame
fifth day of the intervention
Title
Oral mucositis grading
Description
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.
Time Frame
tenth day of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZUHAL ONER SIVIS, MD
Organizational Affiliation
Tepecik Research and Training Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tepecik Research and Training Hospital
City
İzmir
ZIP/Postal Code
35640
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will be decided on demand.

Learn more about this trial

Oral Care With Propolis in Pediatric Oncology Patients

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