| 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
|
|
|
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
|
|
|
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 |