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

Sponsor
Dokuz Eylul University (Other)
Overall Status
Completed
CT.gov ID
NCT04586491
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
4.1
Actual Duration (Months)
9.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Oral care protocol
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, randomised, parallel trial designProspective, randomised, parallel trial design
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients
Actual Study Start Date :
Oct 7, 2019
Actual Primary Completion Date :
Feb 10, 2020
Actual Study Completion Date :
Feb 10, 2020

Arms and Interventions

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.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. development of oral mucositis [until discharge from the hospital an average 1 week]

      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

    Secondary Outcome Measures

    1. severity of oral mucositis [until discharge from the hospital an average 1 week]

      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).

    2. recovery time of oral mucositis [until discharge from the hospital an average 1 week]

      Mucositis Follow-up Form used for the recovery time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gülçin Özalp Gerçeker İzmir Turkey 35100

    Sponsors and Collaborators

    • Dokuz Eylul University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gülçin Özalp Gerçeker, Dokuz Eylul University, Dokuz Eylul University
    ClinicalTrials.gov Identifier:
    NCT04586491
    Other Study ID Numbers:
    • Gülçin Özalp Gerçeker
    First Posted:
    Oct 14, 2020
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mucositis
    Stomatitis
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Oct 19, 2020