| CTRI Number |
CTRI/2023/03/051221 [Registered on: 31/03/2023] Trial Registered Prospectively |
| Last Modified On: |
28/08/2023 |
| 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 feasibility of a new hearing assessment tool(Oto-acoustic Emission) in identifying early and significant amount of hearing loss caused due to Cisplatin (widely used as a chemotherapy drug in cancer patients) chemotherapy in pediatric cancer patients. |
|
Scientific Title of Study
|
Feasibility of Oto-acoustic Emission assessment in identification of early and significant ototoxic hearing loss in pediatric cancer patients receiving Cisplatin based Chemotherapy |
| Trial Acronym |
|
|
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, India
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
|
| 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, India
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
|
| 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, India
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
|
| 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 |
|
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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 |
| Jitesh Sahoo |
Tata Memorial Hospital |
Audiology Services, Basement, Golden Jubilee Building, Room no-09, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai, India
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C222||Hepatoblastoma, (2) ICD-10 Condition: C40||Malignant neoplasm of bone and articular cartilage of limbs, (3) ICD-10 Condition: C56||Malignant neoplasm of ovary, (4) ICD-10 Condition: C62||Malignant neoplasm of testis, (5) ICD-10 Condition: C7A||Malignant neuroendocrine tumors, (6) ICD-10 Condition: C45||Mesothelioma, (7) ICD-10 Condition: H838||Other specified diseases of innerear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Following are the inclusion criteria for enrollment of the study participants.
1.Pediatric cancer patients who are planned to receive Cisplatin based chemotherapy
2.Pediatric cancer patients who must be within the age range of 3-17 years
3.Pediatric cancer patients who must be able to provide consistent and reliable responses in conventional pure-tone audiometry
4.Pediatric cancer patients who must present with normal OAE findings at all the test frequencies; i.e. I. For TEAOE, SNR equal to or greater than 6dBSPLand TEOAE level equal to or greater than 0 dBSPL at all the test frequencies with a minimum overall reproducibility rate of 80%; II. For DPOAE, SNR equal to or greater than 6 dBSPL and DPOAE level equal to or greater than 0 dBSPL with a minimum DP reliability rate of 98%based on DP tolerance level ±2 at all the test frequencies.
|
|
| ExclusionCriteria |
| Details |
Following ear-wise exclusion criteria at the time of enrollment will be taken for the study.
1.Pediatric cancer patients with any middle ear pathology or previous ear surgery
2.Pediatric cancer patients with any known pre-treatment hearing loss documented in baseline audiogram.
3.Pediatric cancer patients with any known cognitive or psychological problems
4.Pediatric cancer patients with any known ototoxic cancer treatment before.
5.Pediatric cancer patients who are planned for cranial radiation therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To test the agreement between PTA and OAE findings in identifying early and significant ototoxic hearing loss in pediatric cancer patients by comparing the results after every two cycles of cisplatin containing chemotherapy, at the end of the treatment and at six of completing treatment. |
PTA and OAE will be assessed:
After every two cycles of cisplatin containing chemotherapy, at the end of the treatment and at six months of completing treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time to reach significant ototoxic hearing loss according to the adopted criteria for each assessment tool (i.e. PTA with grading and OAE) for each ear |
It will be analyzed based on the findings of following timepoints. They are at baseline, after every two cycles of Cisplatin based chemotherapy, at the end of the chemotherapy and at six months of completion of chemotherapy. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/04/2023 |
| 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
|
NA |
|
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 pediatric patients and often causes a permanent hearing
loss. This side effect is refered as ototoxicity and it may significantly
affect the child’s communication, social and academic skills sometimes up to a
disabling degree. In recent years, there has been considerable debate on
adopting different test tools for timely 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 early and significant ototoxic hearing loss according to grades of
hearing loss based on PTA findings.Though, PTA has been the gold standard test
tool for ototoxicity assessment in pediatric patients, OAE has been proved to
be more sensitive than PTA to identify subtle inner ear changes happening in
ototoxic treatments. But,it is less often used in pediatric cancer patients due
to lack of research evidence.
Hence, We
propose to evaluate the effectiveness of OAE assessment in identifying the
presence of early and significant ototoxic hearing loss in pediatric 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 pediatric cancer patients according to
the proposed inclusion/ exclusion criteria. These findings will be subjected to
statistical analysis for agreement in order to check feasibility of OAE
assessment in timely identification of severity of ototoxic hearing loss.
The potential
outcome of the study may have following several clinical applications and
usefulness
•Understand and
characterize the ototoxic hearing loss and its course from audiological point
of view
•Effective design
of the audiological monitoring protocol
•Effective Use of OAE
for very young children and
difficult-to-test population
•Assist in well-informed treatment decision and
counseling. |