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CTRI Number  CTRI/2026/03/105584 [Registered on: 06/03/2026] Trial Registered Prospectively
Last Modified On: 03/03/2026
Post Graduate Thesis   
Type of Trial  Observational 
Type of Study    
Study Design  Other 
Public Title of Study   Develop a tool to measure severity of oral mucositis in cancer patients undergoing treatment modalities 
Scientific Title of Study   A study to develop a chemo-radiation induced oral mucositis assessment scale (CRIO-MAS) to monitor symptoms severity among cancer patients receiving treatment modalities in selected hospitals of Ambala, Haryana 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ritika Kumari  
Designation  M.sc nursing student 
Affiliation  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar Deemed to be university 
Address  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar Deemed to be university, Mullana, Ambala, pin-134003, MHN department, room no. 204
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar Deemed to be university, Mullana, Ambala, pin-134003, MHN department, room no.-204
Ambala
HARYANA
134003
India 
Phone  8295920805  
Fax    
Email  choudharyritu664@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sargungbam Sarju Devi 
Designation  Associate Professor  
Affiliation  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar Deemed to be university 
Address  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar Deemed to be university, Mullana, Ambala, pin-134003, MSN department, room no. 201
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar Deemed to be university, Mullana, Ambala, pin-134003, MSN department, room no.-201
Ambala
HARYANA
134003
India 
Phone  7497884937  
Fax    
Email  sarju.mmcn@mmumullana.org  
 
Details of Contact Person
Public Query  
Name  Sargungbam Sarju Devi 
Designation  Associate Professor  
Affiliation  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar Deemed to be university 
Address  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar Deemed to be university, Mullana, Ambala, pin-134003, MSN department, room no. 201
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar Deemed to be university, Mullana, Ambala, pin-134003, MSN department, room no.-201
Ambala
HARYANA
134003
India 
Phone  7497884937  
Fax    
Email  sarju.mmcn@mmumullana.org  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Maharisi Markandeshwar Deemed to be university 
Address  M.M. college of Nursing, Maharishi MarkandeshwarDeemed to be university, Mullana, Ambala 
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 
Sarungbam Sarju Devi  Maharishi Markandeshwar deemed to be university.  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar Deemed to be university, Mullana, Ambala, pin-134003, Distt-Ambala, Haryana, MSN department, room no. 201 Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar Deemed to be university, Mullana, Ambala, pin-134003, Distt-Ambala, Haryana, MHN department, room no.-204
Ambala
HARYANA 		 7497884937

sarju.mmcn@mmumullana.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MMIS&R Mullana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C768||Malignant neoplasm of other specified ill-defined sites,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  to monitor symptom severity of oral mucositis on Cancer patients undergoing chemotherapy radiation therapy and combination therapy  
 
ExclusionCriteria 
Details  patient who are under the age group of 18 years, patients with the comorbidities like HIV/AIDS, MODS, Tuberculosis.and patients who are not willing to participate in study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to monitor symptom severity among cancer patients receiving treatment modalities by CRIO-MAS tool   2 months  
 
Secondary Outcome  
Outcome  TimePoints 
to make scale more reliable and valid to asses the severity of mucositis among cancer patients   
reliability and validity of CRIO-MAS scale  1month 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   30/03/2026 
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="1"
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 validate a chemo-radiation-induced oral mucositis assessment scale (CRIOMAS) for cancer patients receiving chemotherapy, radiotherapy or both. Oral mucositis is a common treatment-related complication that affects the oral and nutritional status of patients. Existing tools do not fully capture both clinical signs and patient-reported symptoms. Therefore, CRIOMAS has been designed with fourteen parameters using a graded Likert scale to assess severity and functional impact. The study will test the validity, reliability, sensitivity and specificity of the scale by comparing it with established assessment methods. The tool is expected to provide a standardised and practical method for early detection and monitoring of oral mucositis in oncology settings. 
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