The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients

Pediatric Cancer Clinical Trial

Official title:

The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04586491
• Other study ID #: Gülçin Özalp Gerçeker
• Status: Completed
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: February 10, 2020

Study information

• Verified date: October 2020
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study conducted to determine the effects of two oral care protocols containing sodium bicarbonate or saline solution in the prevention of oral mucositis (OM), mucositis degree, and recovery time in children with cancer.

Description:

The study conducted as a randomized controlled trial with a parallel design with two groups; Study group/ Oral care protocol with saline solution Control group/ Oral care protocol with sodium bicarbonate solution

Study Hypothesis; There is a difference in oral mucositis (OM) between groups. There is a difference in the degree of OM between groups. There is a difference in the OM recovery time between groups. There is a difference in demographic variables in patients with and without mucositis.

The study sample was comprised of 43 children with cancer aged 1-17 years, received chemotherapy for ≥3 days at inpatient clinics, and whose families agreed to their participation in the study. Patients excluded who have oral ulceration or mucositis, taking any antiviral or antifungal therapy for OM before enrollment in the study. This trial was a triple blinded which the patients/parents, nurses, and the investigators have no idea about the groups.

In the study, patients were allocated by the blocked randomization. After naturally separating the gender variable into 2 layers, the age was divided into 5 layers as "<1 year, 1-3 years,>3-6 years, 6-12 years,>12 years", and the diagnosis variable was divided into 3 layers as "ALL, AML and oncological tumors."

Socio-Demographic Data Collection Form, International Child Mucositis Rating Scale (CHIMES), and Mucositis Follow-up Form used.

The child who do not have mucositis and who will be hospitalized for more than 3 days for chemotherapy will be distributed to the groups by stratified randomization method, the information of the patients will be obtained with the sociodemographic data collection form, oral care training will be given to the patient and the family, oral care protocol will be applied and it will be evaluated daily with the CHIMES and Mucositis Follow-up Form, and the severity of mucositis according to the World Health Organization Mucositis Assessment Index, the mean score of the CHIMES, recovery time will be monitored through the Mucositis Follow-up Form.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

Inclusion Criteria:

• have cancer, aged 1-17 years, received chemotherapy for =3 days at inpatient clinics and whose families agreed to their participation in the study.

Exclusion Criteria:

• who have oral ulceration or mucositis, in terminal period, taking any antiviral or antifungal therapy for OM before enrollment in the study.

Related Conditions & MeSH terms

• Mucositis
• Oral Cavity
• Pediatric Cancer
• Stomatitis

Intervention

Combination Product:
• Oral care protocol
Oral care protocol

Locations

Country	Name	City	State
Turkey	Gülçin Özalp Gerçeker	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of oral mucositis	WHO Oral Mucositis Grading Scale: The WHO scale is dependent on both objective and subjective variables, and measures anatomical, symptomatic as well as functional components of oral mucositis.; WHO Oral Mucositis Grading Scale	until discharge from the hospital an average 1 week
Secondary	severity of oral mucositis	WHO Oral Mucositis Grading Scale: The WHO scale is dependent on both objective and subjective variables, and measures anatomical, symptomatic as well as functional components of oral mucositis.; the Children's International Mucositis Evaluation Scale (ChIMES):It consists of seven elements: (1) Amount of mouth or throat pain(ChIMES1), (2) Effect of mouth or throat pain on swallowing(ChIMES2), (3) Effect of mouth or throat pain oneating (ChIMES3), (4) Effect of mouth or throat pain ondrinking (ChIMES4), (5) Receipt of pain medication (ChIMES5),(6) Receipt of pain medication for mouth or throat pain(ChIMES6), and (7) Presence of ulcers (ChIMES7).	until discharge from the hospital an average 1 week
Secondary	recovery time of oral mucositis	Mucositis Follow-up Form used for the recovery time	until discharge from the hospital an average 1 week