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CTRI Number  CTRI/2025/09/094222 [Registered on: 04/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Single Arm Study 
Public Title of Study   Improving Oral Care to Reduce Mouth Problems in Children Receiving Chemotherapy 
Scientific Title of Study   Development and Implementation of an Evidence-Based Oral Care Bundle to Reduce the incidence and severity of Oral Mucositis among children with cancer Receiving Chemotherapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjana G N 
Designation  Staff Nurse 
Affiliation  Malabar Cancer Centre - Post Graduate Institute of Oncology Sciences and Research 
Address  Department of Onco Nursing Malabar Cancer Centre

Kannur
KERALA
670692
India 
Phone  9497641912  
Fax    
Email  anjuanjanagn@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anjana G N 
Designation  Staff Nurse 
Affiliation  Malabar Cancer Centre - Post Graduate Institute of Oncology Sciences and Research 
Address  Department of Onco Nursing Malabar Cancer Centre

Kannur
KERALA
670692
India 
Phone  9497641912  
Fax    
Email  anjuanjanagn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anjana G N 
Designation  Staff Nurse 
Affiliation  Malabar Cancer Centre - Post Graduate Institute of Oncology Sciences and Research 
Address  Department of Onco Nursing Malabar Cancer Centre

Kannur
KERALA
670692
India 
Phone  9497641912  
Fax    
Email  anjuanjanagn@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Malabar Cancer Centre Post Graduate Institute of Oncology Sciences and Research 
Address  Kodiyeri Muzhikkara MCC Rd Illathaazha Thalassery Kerala pin 670103 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jithin T K  Malabar Cancer Centre Post Graduate Institute of Oncology Sciences and Research  Department of Onco Nursing Kodiyeri Muzhikkara MCC Rd Illathaazha Thalassery
Kannur
KERALA 		 97453 07825

drjithinmcc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutionnal Ethics Committee Malabar Cancer Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], (2) ICD-10 Condition: C402||Malignant neoplasm of long bones of lower limb, (3) ICD-10 Condition: C810||Nodular lymphocyte predominant Hodgkin lymphoma, (4) ICD-10 Condition: C920||Acute myeloblastic leukemia, (5) ICD-10 Condition: C717||Malignant neoplasm of brain stem, (6) ICD-10 Condition: C692||Malignant neoplasm of retina,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  oral care bundle  The intervention consists of a structured oral care bundle including regular oral hygiene with fluoride toothpaste, cryotherapy (popsicles), application of honey, and lip protection with lanolin-based balm. The bundle is supported by caregiver education, nurse training, and compliance monitoring tools to ensure consistent implementation and effectiveness in reducing the incidence and severity of oral mucositis. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Children aged 1 to 14 years diagnosed with cancer. Children receiving chemotherapy agents known to carry a high risk of causing oral mucositis as inpatients.
Children who can be monitored for mucositis for up to 14 days after receiving chemotherapy.
Parents or caregivers who give informed consent.
 
 
ExclusionCriteria 
Details  •Children with congenital anomalies or other severe comorbidities that may interfere with oral care assessments.
•Children who have initiated their chemotherapy regimen in other units or hospitals, outside the study setting.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduce the incidence and severity of Oral Mucositis among children Receiving Chemotherapy  Day 1 to day 14 of chemotherapy 
 
Secondary Outcome  
Outcome  TimePoints 
Change in nursing knowledge score (pre-test,post-test)  Immediately pre-training and immediately post-training  
percentage of children maintaining adequate oral intake during 1–14 Days of chemo   post-implementation (Day 1–14 of chemo cycles) 
Caregiver satisfaction score  Post-implementation - during discharge 
Caregiver adherence rate to bundle tasks  Daily during hospitalization 
Nurse satisfaction score with bundle implementation  At 1 month post-implementation (and optionally at 3 and 6 months) 
Nurse adherence rate to bundle  Weekly during implementation period 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Oral mucositis (OM) is a frequent and debilitating complication of chemotherapy in pediatric oncology patients, leading to pain, poor nutrition, infection risk, and treatment interruptions. Current oral care practices are inconsistent and lack standardization. This study aims to develop, validate, and implement an evidence-based oral care bundle, incorporating daily oral hygiene, cryotherapy, topical agents (fluoride toothpaste, lanolin-based lip balm, honey), and caregiver/nurse education.

The project will be conducted in a single-arm design at a tertiary pediatric oncology center. Eligible children initiating chemotherapy will be followed from Day 1 up to Day 14 for the development and severity of OM, assessed using CTCAE v5 criteria during each nursing shift. Compliance checklists for nurses and caregivers will be used to monitor adherence.

This project is expected to standardize oral care practices, reduce the burden of OM, improve treatment tolerance, and enhance the quality of life of children undergoing chemotherapy.

 
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