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

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.

Study Overview

• Status: Completed
• Conditions: Mucositis; Pediatric Cancer; Oral Cavity
• Intervention / Treatment: Combination product: Oral care protocol

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35100
    • Gülçin Özalp Gerçeker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group/ Oral care protocol with saline solution; All patients took oral care protocol in the unit with saline solution	Combination product: Oral care protocol; Oral care protocol; Other Names: Daily evaluation of the inside of the mouth with the ChIMES; Gargle with solution; wiping the inside of the mouth with solution and sterile sponge; Brushing teeth with a soft toothbrush if platelet value was > 50000mm3.; Training for the child and family in oral care.
Experimental: Control group/ Oral care protocol with sodium bicarbonate solution; All patients took oral care protocol in the unit with sodium bicarbonate solution	Combination product: Oral care protocol; Oral care protocol; Other Names: Daily evaluation of the inside of the mouth with the ChIMES; Gargle with solution; wiping the inside of the mouth with solution and sterile sponge; Brushing teeth with a soft toothbrush if platelet value was > 50000mm3.; Training for the child and family in oral care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
recovery time of oral mucositis	Mucositis Follow-up Form used for the recovery time	until discharge from the hospital an average 1 week

Collaborators and Investigators

• Sponsor: Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Actual): February 10, 2020
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis; Pharmaceutical Solutions
• Other Study ID Numbers: Gülçin Özalp Gerçeker

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No