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CTRI Number  CTRI/2023/12/060500 [Registered on: 18/12/2023] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Single Arm Study 
Public Title of Study   Checking the effectiveness of a new hearing assessment (Oto-acoustic Emission) in identifying hearing loss caused due to Cisplatin (widely used as part of cancer treatment) in adult cancer patients.  
Scientific Title of Study   Feasibility of Oto-acoustic Emission assessment in identification of ototoxic hearing loss in adult individuals with cancer receiving Cisplatin based Chemo-radiotherapy. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  jitesh prasad sahoo 
Designation  Scientific Officer (Audiology) 
Affiliation  Tata Memorial Hospital 
Address  Audiology Services, Department of Head and Neck Oncology, Golden Jubilee Building, Basement Room no-09, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9437491391  
Fax    
Email  jitesh.aslp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  jitesh prasad sahoo 
Designation  Scientific Officer (Audiology) 
Affiliation  Tata Memorial Hospital 
Address  Audiology Services, Department of Head and Neck Oncology, Golden Jubilee Building, Basement Room no-09, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9437491391  
Fax    
Email  jitesh.aslp@gmail.com  
 
Details of Contact Person
Public Query
 
Name  jitesh prasad sahoo 
Designation  Scientific Officer (Audiology) 
Affiliation  Tata Memorial Hospital 
Address  Audiology Services, Department of Head and Neck Oncology, Golden Jubilee Building, Basement Room no-09, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9437491391  
Fax    
Email  jitesh.aslp@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital. Dr. Ernest Borges Road. Parel. Mumbai Pin-400012 
 
Primary Sponsor  
Name  Tata Research Administrative Council 
Address  Tata Memorial Hospital, 3rd floor, Main Building, Dr. Ernest Borges Road, Parel, Mumbai, India-400012 
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 
Dr Jitesh Prasad Sahoo  Tata Memorial Hospital  Audiology Services, Basement, Golden Jubilee Building, Room no-09
Mumbai (Suburban)
MAHARASHTRA 
9437491391

jitesh.aslp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-II, Institutional Review Board, 3rd floor, Main Building, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel. Mumbai. Pin-400012  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Following are the inclusion criteria for enrollment of the study participants.
1-Head-neck cancer patients who are planned to receive Cisplatin-based definitive or adjuvant chemo-radiotherapy
2-Head-neck cancer patients who are able to provide consistent and reliable responses in conventional pure-tone audiometry.
3-Head-neck cancer patients who have not received any known ototoxic cancer treatment before.
4-Head-neck cancer patients without any known cognitive or psychological problems 
 
ExclusionCriteria 
Details  Following ear-wise exclusion criteria at the time of enrollment will be taken for the study.
1-Ears of Head-neck cancer patients with air Conduction Hearing thresholds >50dBHL at any of the octave-band test frequencies between 0.5 to 8 KHz.
2-Ears of Head-neck cancer patients with Distortion Product Oto-acoustic Emission (DPOAE)Signal to Noise Ratio (SNR) level < 6 dBSPL and/ or absolute DPOAE amplitude < -10dBSPL at any two test frequencies between 1.5 to 6KHz
3-Ears of Head-neck cancer patients with presence of any Conductive hearing loss at baseline or at end-of-treatment evaluation.
4-Ears of Head-neck cancer patients with a history of previous ear surgery
5-Ears of Head-neck cancer patients with any known pre-treatment hearing loss documented in baseline audiogram.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To establish the criteria of ototoxic hearing loss with highest agreement between interpretation of PTA and OAE findings between 1.5 to 6 kHZ  It will be analyzed based on the audiological findings within three months of completion of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
To check any significant audiological changes in findings of PTA & DPOAE across all time points.
 
It will be analyzed based on the findings of the evaluation conducted after two cycles of chemotherapy & follow up evaluation conducted within three months of completion chemotherapy. 
To check the agreement between interpretation of PTA & DPOAE findings based on the newly set criteria of defining auditory abnormality at all other time points.
 
It will be analyzed based on the findings of the evaluation conducted after two cycles of chemotherapy 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   25/12/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Cisplatin is a medicine that is being administered as part several chemotherapy protocols for many types of cancer in adult patients and often causes a permanent hearing loss. This side effect is referred as ototoxicity and it may negatively affect the patients post-treatment quality of life. In recent years, there has been considerable debate on adopting different test tools for timely of identification hearing loss caused by cancer and its treatment that will facilitate effective management of ototoxic hearing loss.

Pure-tone Audiometry (PTA) is a routinely used test to identify overall hearing loss and Oto-acoustic Emission (OAE) is an objective test usually done  to check the integrity of the inner ear. We can identify  ototoxic hearing loss based on PTA findings. Though, PTA has been the gold standard test tool for ototoxicity assessment in adult cancer patients, OAE is thought to be more sensitive than PTA to identify subtle inner ear changes happening in ototoxic treatments. However, it is less often used in cancer patients due to lack of research evidence.

Hence, We propose to evaluate the effectiveness of OAE assessment in identifying the presence of ototoxic hearing loss in adult cancer patients receiving Cisplatin based chemotherapy by comparing with Pure-tone Audiometry (PTA) findings during the course chemotherapy.

PTA and OAE findings will be obtained before, during and after the administration of Cisplatin based chemotherapy in eligible adult cancer patients according to the proposed inclusion/ exclusion criteria. These findings will be subjected to statistical analysis for agreement to check feasibility of OAE assessment in timely identification of ototoxic hearing loss.

The potential outcome of the study may have several clinical applications and usefulness as follows.

1-To understand and characterize the ototoxic hearing loss and its course from audiological point of view which may help us to identify patients earlier if feasible and also counsel them regarding the long term effects.

2-To establish a relationship among audiological indicators of ototoxicity over time and to design the audiological monitoring protocol accordingly in order to prevent and manage ototoxic hearing loss effectively.

3-To design ototoxicity monitoring protocol by using OAE for difficult-to-test population, who may not provide reliable responses in subjective hearing evaluations like Pure-tone Audiometry.

4-To decide upon well-informed treatment decision and counseling

 
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