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CTRI Number  CTRI/2014/08/004940 [Registered on: 28/08/2014] Trial Registered Retrospectively
Last Modified On: 27/08/2014
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   STUDY TO ASSESS HEARING LOSS IN PATIENTS RECEIVING SIMULTANEOUS CHEMOTHERAPY AND RADIATION THERAPY FOR HEAD AND NECK CANCERS 
Scientific Title of Study   STUDY TO ASSESS HEARING LOSS IN PATIENTS RECEIVING CHEMORADIOTHERAPY IN ADJUVANT SETTING FOR HEAD AND NECK MALIGNANCY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR VANI KRISHANA GUPTA 
Designation  RESIDENT 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  DEPARTMENT OF ENT, FATHER MULLER MEDICAL COLLEGE, KANKANADY, MANGALORE

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9900405811  
Fax    
Email  vanikrishanagupta@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  DR MAHESH BHAT 
Designation  ASSOCIATE PROFESSOR 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  DEPARTMENT OF ENT, FATHER MULLER MEDICAL COLLEGE, KANKANADY, MANGALORE

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9886734374  
Fax    
Email  mahesh.t.bhat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR VANI KRISHANA GUPTA 
Designation  RESIDENT 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  DEPARTMENT OF ENT, FATHER MULLER MEDICAL COLLEGE, KANKANADY, MANGALORE

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9900405811  
Fax    
Email  vanikrishanagupta@yahoo.com  
 
Source of Monetary or Material Support  
FATHER MULLER MEDICAL COLLEGE 
 
Primary Sponsor  
Name  FATHER MULLER MEDICAL COLLEGE 
Address  FATHER MULLER MEDICAL COLLEGE, KANKANADY, MANGALORE 575002 
Type of Sponsor  Private medical 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 VANI KRISHANA GUPTA  In patients of departments of ENT and radiation Oncology in Father Muller hospital  FATHER MULLER MEDICAL COLLEGE, KANKANADY, MANGALORE
Dakshina Kannada
KARNATAKA 
9900405811

vanikrishanagupta@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLER MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  SUFFERING FROM HEAD AND NECK MALIGNANCIES,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  INDIVIDUALS SUFFERING FROM HEAD AND NECK MALIGNANCIES RECEIVING CHEMO-RADIATION FOR THE SAME WITH TEMPORAL BONE IN THE RADIATION FIELD.
INDIVIDUALS WILLING FOR TIMED AUDIOLOGICAL ASSESSMENT.  
 
ExclusionCriteria 
Details  INDIVIDUALS ALREADY SUFFERING FROM PROFOUND HEARING LOSS AND RECEIVING NEOADJUVANT CHEMORADIOTHERAPY 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
HEARING LOSS IN DECIBELS ACHIEVED BY PURE TONE AUDIOMETRY  PRE THERAPY, 3 WEEKS AFTER INITIATING THERAPY, AT THE COMPLETION OF THERAPY, 3 MONTHS FOLLOW UP 
 
Secondary Outcome  
Outcome  TimePoints 
DEGREE OF SEVERITY AND TYPE OF HEARING LOSS  PRE THERAPY, 3 WEEKS AFTER INITIATING THERAPY, AT THE COMPLETION OF THERAPY, 3 MONTHS FOLLOW UP 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/09/2013 
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="1"
Months="11"
Days="1" 
Recruitment Status of Trial (Global)   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  

                Head and neck cancers in India account for 30% of all cancers. In India, 60 to 80 % of patients present with advanced disease as compared to 40% in developed countries. Chemoradiotherapy (CTRT) is the most common modality of treatment for advanced head and neck cancers.

                Radiation induced sensorineural hearing loss (SNHL) is an important side effect as the temporal bone is often included in the field of radiation. It is usually high frequency SNHL that occurs either during or 6-24 months after therapy and may progress to complete deafness. The widely used chemotherapeutic drug, cisplatin, is also known to cause ototoxicity, thus adding to the SNHL.

                  This hearing impairment can cause significant disability in these patients especially in cases of binaural hearing loss, hence this should be kept in mind during the pre- radiotherapy counseling and post-radiotherapy follow-up of these patients. Many of the previous reports were based on studies that were either retrospective or involved a limited number of patients. The aim of this study is the qualitative and quantitative assessment of hearing loss in patients receiving CTRT in adjuvant settings for head and neck malignancy.

 
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