Skip to main content
Clinical Trials/CTRI/2023/03/051221
CTRI/2023/03/051221
Recruiting
未知

Feasibility of Oto-acoustic Emission assessment in identification of early and significant ototoxic hearing loss in pediatric cancer patients receiving Cisplatin based Chemotherapy

Tata Research Administrative Council0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Tata Research Administrative Council
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational

Investigators

Sponsor
Tata Research Administrative Council

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

Similar Trials