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CTRI Number  CTRI/2024/12/078685 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 29/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Dentistry
Process of Care Changes
Behavioral 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Developing Oral Care Guidelines for the Indian Pediatric Oncology Population 
Scientific Title of Study   A Study to Develop Evidence Informed Oral Care Guidelines for Indian Context and Find its Effectiveness on Oral Health Status of 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  Meghna Pandit 
Designation  PhD Scholar 
Affiliation  Manipal College of Nursing, MAHE, Manipal 
Address  Department of Child Health Nursing, First Floor, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  8073700025  
Fax    
Email  meghna1.mconmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Meghna Pandit 
Designation  PhD Scholar 
Affiliation  Manipal College of Nursing, MAHE, Manipal 
Address  Department of Child Health Nursing, First Floor, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  8073700025  
Fax    
Email  meghna1.mconmpl2023@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Baby S Nayak 
Designation  Professor and Head 
Affiliation  Manipal College of Nursing, MAHE, Manipal 
Address  Department of Child Health Nursing, Manipal College of Nursing, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9632217067  
Fax    
Email  baby.s@manipal.edu  
 
Source of Monetary or Material Support  
Dr. T.M.A Pai Scholarship for full-time PhD Scholars, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104, India 
 
Primary Sponsor  
Name  Manipal College of Nursing, Manipal Academy of Higher Education 
Address  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka - 576104 
Type of Sponsor  Other [Private Nursing College] 
 
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 Vasudeva Bhat K  Kasturba Hospital, Manipal  Pediatric Oncology Ward (Division of Pediatric Hematology and Oncology), Ground Floor, Kasturba Hospital, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 		 7625032075

vasudev.bhat@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Evidence Informed Oral Care Guidelines  The intervention focuses on developing and implementing Evidence-Informed Oral Care Guidelines for pediatric cancer patients. These guidelines will be developed based on data from focus group discussion, and systematic reviews, and will be supported by educational programs for parents of children with cancer, along with sensitization of staff nurses working in pediatric oncology wards regarding the importance and usage of the Evidence Informed Oral Care Guidelines, to improve oral health outcomes during cancer treatment. The components include: 1. Oral Care Kit: A customized oral care kit will be prepared based on the guidelines, containing essential oral care products and clear instructions for use. Parents and caregivers will receive training to ensure its proper usage. 2. Education and training for Parents: Informational sessions will cover topics such as cancer, chemotherapy, radiation therapy, the importance of oral care, and best oral hygiene practices. A booklet summarizing this information will also be provided. The parents will also participate in a 2–3-day training program (1 hour daily) to learn how to integrate the guidelines into their child’s daily oral care routine, with active involvement encouraged. 3. Training for Staff Nurses: Nurses in pediatric oncology wards will undergo a 4–5-day training (1 hour daily) to familiarize themselves with the guidelines, monitor their implementation, and support parents and children in adhering to them. 4. Dietary Guidance: Parents will receive specific guidance on nutrition to prevent and manage oral complications during cancer treatment. This includes educational sessions, sample meal plans, and ongoing support to improve oral and overall health. 
Comparator Agent  Standard Care  Standard oral hygiene and care practiced by children receiving treatment for cancer at hospital i.e. regular toothbrushing, use of chlorhexidine mouthwash and Candid mouth-paint as required. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children aged 5 to 18 years, whose parents give consent to participate in the study.
Parents who are able to read and understand Kannada or English.
Children in the ‘induction’ phase of chemotherapy or receiving Neoadjuvant Chemotherapy (NACT)
Children receiving chemotherapy, radiation therapy, or a combination of both. 
 
ExclusionCriteria 
Details  Children with cancer on best supportive care.
Children with severe oral health conditions unrelated to cancer such as severe periodontal disease, congenital oral malformations. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Oral health status of children
Oral care practices followed by caregivers and children 		 2-3 assessments during in-patient stay, twice-monthly assessments during next 6 months of follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Knowledge level of parents and staff nurses on oral care practices  2-3 assessments during in-patient stay, twice-monthly assessments during next 6 months of follow up 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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   Phase 4 
Date of First Enrollment (India)   01/01/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This study aims to develop and evaluate evidence-based oral care guidelines tailored for children with cancer to prevent and manage oral complications during treatment. The study involves observing current practices, engaging stakeholders via focus group discussions, and implementing interventions including training and education of nursing staff and parents of children with cancer, and the use of specifically curated oral care kits for such children. The guidelines will be pretested for feasibility and finalized before assessing their effectiveness in improving oral health outcomes among pediatric cancer patients. 
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