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CTRI Number  CTRI/2013/08/003906 [Registered on: 21/08/2013] Trial Registered Retrospectively
Last Modified On: 18/08/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effect of oral ice application in preventing oral ulcer associated with radiotherapy among cancer patients undergoing radiotherapy. 
Scientific Title of Study   A randomised controlled trial to assess the effect of ‘oral ice application’ in preventing mucositis associated with radiotherapy among cancer patients undergoing radiotherapy at regional cancer centre, PGIMER, Chandigarh 2012-13. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naseem M 
Designation  MSc – Medical Surgical Nursing (Oncology Nursing) 2nd year student 
Affiliation  National Institute of Nursing Education (NINE) PGIMER, Chandigarh, India 
Address  Naseem M MSc – Medical Surgical Nursing (Oncology Nursing) 2nd year National Institute of Nursing Education (NINE) PGIMER, Chandigarh, India
Kurikkal (H) Udirampoyil, Pullangode Post Kalikavu (Via) Malappuram District. Kerala 676525
Chandigarh
CHANDIGARH
160012
India 
Phone  09914269392  
Fax    
Email  naseemmancheri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukhpal Kaur 
Designation  Lecturer 
Affiliation  National Institute of Nursing Education (NINE) PGIMER, Chandigarh, India 
Address  National Institute of Nursing Education (NINE) PGIMER, Chandigarh, India

Chandigarh
CHANDIGARH
160012
India 
Phone  09888536964  
Fax    
Email  sukhpal.trehan@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Naseem M 
Designation  MSc – Medical Surgical Nursing (Oncology Nursing) 2nd year student 
Affiliation  National Institute of Nursing Education (NINE) PGIMER, Chandigarh, India 
Address  Naseem M MSc – Medical Surgical Nursing (Oncology Nursing) 2nd year National Institute of Nursing Education (NINE) PGIMER, Chandigarh, India
Kurikkal (H) Udirampoyil, Pullangode Post Kalikavu (Via) Malappuram District. Kerala 676525

CHANDIGARH
160012
India 
Phone  09914269392  
Fax    
Email  naseemmancheri@gmail.com  
 
Source of Monetary or Material Support  
Infrastructural support by Department of Radiotherapy, Regional Cancer Centre, PGIMER, Chandigarh No monetory support from any source  
 
Primary Sponsor  
Name  Naseem M 
Address  MSc – Medical Surgical Nursing (Oncology Nursing) 2nd year student National Institute of Nursing Education (NINE) PGIMER Chandigarh 
Type of Sponsor  Other [Principal Investigator himself] 
 
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 
Prof Dr Sushmita Ghoshal  Department of Radiotherapy  Department of Radiotherapy,Regional Cancer Centre, PGIMER, Sector 12, chandigarh-160012
Chandigarh
CHANDIGARH 		 9914209394

rtsushmita@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committe, PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Oral mucositis among Head and Neck cancer patients who were undergoing for radical radiotherapy.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral ice application, Routine management (Dispirine gargle, Mucaine gel)   Experimental group: Oral ice application [ providing ice cubes (3.5cm ×2cm×2cm) for subjects to hold in mouth for 4 minute before and after radiotherapy ] along with routine management (Dispirine gargle, Mucaine gel)  
Comparator Agent  Routine management (Dispirine gargle, Mucaine gel)  Control group : follows routine management (Dispirine gargle, Mucaine gel) only. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult males or females diagnosed with head and neck cancer and planned for radical radiotherapy and having normal mucosa 
 
ExclusionCriteria 
Details  Patients diagnosed with head and neck cancer and planned for palliative radiotherapy.
Patients who are coming for booster dose of radiation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Oral mucositis was assessed with the help of WHO oral toxicity scale and Low grade of mucositis was observed in interventional group as comparing with control group.
Delay in the development of oral mucositis was also noted in the interventional group as compared to control group  		 Oral mucositis was assessed on 1st day of radiotherapy prior to treatment,
On end of 1st week of treatment i.e. on 5th day of the treatment,
On end of 2nd week of treatment i.e. on 10th day of the treatment,
On end of 3rd week of treatment i.e. on 15th day of the treatment,
On end of 4th week of treatment i.e. on 20th day of the treatment.
 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of ice application on tumour size and response   Follow up visits by the patient. But this was not conducted due to limited time period 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/07/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="4" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   there is no similar publication from raditherapy.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Abstract

Background: Oral mucositis is a common side effect of radiotherapy. No effective intervention reported for its prevention and management. The goal of this study was to assess the effect of ‘oral ice application’ for the prevention of radiotherapy associated mucositis.
Methods: The present study was carried out in the Radiotherapy unit of Regional Cancer Centre, PGIMER, Chandigarh over a period of six months. In this randomized controlled trial, newly diagnosed head and neck cancer patients undergoing radical radiotherapy were allocated into experimental and the control groups of 30 patients each. The patients in the experimental group were asked to hold ice cube in mouth for 4 minutes before and after radiotherapy along with routine care till the completion of their treatment. And the patients in control group were continued with routine care. Oral mucositis was assessed on 1st, 5th, 10th, 15th, and 20th day of radiotherapy by using WHO oral toxicity scale. Data analysis was done by using chi square test and Fisher’s exact test at 0.05 level of significance.
Results: Majority (93%) of the subjects was males and 70% of the subjects were having the habit of smoking before beginning the treatment. Grade 1 mucositis reported in experimental group on 10th day of the treatment. But in control group it was noted on 5th day. After the intervention, a significant lower incidence of mucositis was found in experimental group on 10th day of treatment (p< 0.05). Grade 3 mucositis was reported only in the control group on 20th day (p>0.05).
Conclusions: This study shows that ‘oral ice application’ was useful for delaying the mucositis and reducing the severity of mucositis. However further studies are essential to confirm this observation. 
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