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CTRI Number  CTRI/2015/04/005709 [Registered on: 21/04/2015] Trial Registered Retrospectively
Last Modified On: 18/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effectiveness of an oral care protocol in cancer patients receiving chemotherapy and radiation therapy. 
Scientific Title of Study   “Development and evluation of an Oral care protocol on chemotherapy and radiation therapy induced oral complications in cancer patients: single blind, randomized clinical trial” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Radhika R Pai 
Designation  Assistant Professor Department of Medical Surgical Nursing, School of Nursing, KMC Mangalore 
Affiliation  Manipal School of Nursing 
Address  Manipal School of Nursing Centre for Basic Sciences Bejai KMC Mangalore DK District Karnataka State India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  09844579359  
Fax    
Email  radhika.r@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravikiran Ongole 
Designation  Professor, Department of Oral Medicine and Radiology  
Affiliation  Manipal College of Dental Sciences Mangalore 
Address  Manipal College of Dental Sciences LHH Road Mangalore. DK District Karnataka State India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9448430387  
Fax    
Email  ravikiran.ongole@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sourjya Banerjee  
Designation  Assistant Professor, Department of Radiation Oncology 
Affiliation  KMC Hospital Attavara Mangalore 
Address  KMC Hospital Attavara Mangalore. DK District Karnataka State India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9880345339  
Fax    
Email  sourjya.banerjee@gmail.com  
 
Source of Monetary or Material Support  
KMC Hospital Attavara Mangalore Dakshina Kannada District Karnataka State 575001 
 
Primary Sponsor  
Name  Radhika R Pai 
Address  Manipal School of Nursing Centre for Basic Sciences Bejai KMC Mangalore DK District Karnataka India 575001 
Type of Sponsor  Other [] 
 
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 
Radhika R Pai  KMC HOSPITAL  KMC HOSPITAL Attavar Mangalore 575001
Dakshina Kannada
KARNATAKA 		 08242445858

radhika.r@manipal.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Kasturba Medical College Mangaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Cancer patients admitted for Chemotherapy/Radiation therapy/Chemoradiation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control: Standard of care (SOC) of oral care.   Description of the interventions: Patients in this control arm receive oral care according to SOC of oral care as per the hospital practices. It includes Nursing assessment which comprises of – Inspecting mouth (mucous membranes, lips, tongue, and gingiva) for oral changes like mucositis, ulcer, white patches. Documenting findings in the nursing care sheet, Assisting patient with oral care as required.  
Intervention  Experimental arm: Oral Care Protocol  Description of the interventions: Patient in this arm receive oral care according to protocol which includes nursing assessment with oral health assessment tool and oral care kit which contains ultrasoft bristle toothbrush, fluoridated toothpaste, oral rinses (salt, baking soda), chewy tubes, mirror, pen torch, denture brush and denture container, ice cube box, water bottle, patient educational material (Oral care during treatment and after discharge, Menu plan during the treatment). Patient receives intervention from day 1 of admission, till he/she completes the treatment and there after upto 1 year following completion of cancer chemotherapy/ radiation therapy.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both

Chemotherapy Patient Group
Patient inclusion criteria
Patients newly diagnosed to have cancer and receiving selected mucotoxic chemotherapy drugs.
Patients admitted in Medical Oncology wards and special wards.
Patients who are willing to participate in the study.

Radiation Therapy Patient Group
Patient inclusion criteria
Patients admitted in Radiation Oncology and special wards
Patients planned for the radiation to the head and neck area.
Patients who are in any stage of cancer receiving chemoradiation, only radiation or post-operative radiation.
Atleast 75% of both parotids are within the radiation field.
Patients who are willing to take part in the study.
 
 
ExclusionCriteria 
Details  Patient exclusion criteria
Patients with cancers other than those affecting the oropharyngeal region
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Occurrence of oral complications by using oral health assessment sheet   Patient assessment once a week during admission for Radiation/chemoratiation. Patient assessment once in every cycle of chemotherapy. Followup assessment once in two months after discharge upto 1 year following Radiation therapy/Chemoradiation/chemotherapy. 
 
Secondary Outcome  
Outcome  TimePoints 
Functional activities of the mouth (swallowing, taste, pain, self oral care) by using a checklist  1 year 
Duration of Hospitalization
 		 During hospitalization.
Counted from date of admission until discharge.
 
Cost analysis:
Loss of productive days for patient/ relative, extra consultation costs due to complications, extra costs like food, transportation, length of stay.  		 During hospitalization 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/09/2014 
Date of Study Completion (India) 30/11/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/11/2018 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is a randomized, single blind, parallel group; trial for evaluating the effectiveness of oral care protocol for chemotherapy and radiation therapy induced oral complications among cancer patients. Experimental arm in this study will be receiving oral care protocol intervention and control arm participants will be receiving standard of care of oral care. The primary outcome measures will be occurrence of oral complications developed during the cancer treatment and from there after upto 1 year. The secondary outcomes will be duration of hospitalization and cost analysis related to occurrence of oral complications.

 
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