Ototoxicity and hearing outcome in pediatric oncology patients receiving cisplati

Completed

• Conditions: sensorineural hearing lossototoxicity; ototoxicity; cisplatin; Thai pediatric solid tumors; long term outcome

• Registration Number: TCTR20210221001
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-12-31
• Study Start: 2021-02-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

1.pediatric solid tumor patients including neuroblastoma, hepatoblastoma, osteosarcoma, and germ cell tumor who were younger than 15 years old and received cisplatin-based chemotherapy at the Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand from January, 2007 to December, 2019, 2.Patients were evaluated baseline hearing with audiogram and/or auditory steady-state response (ASSR) pre- or within 1 month of initiation of cisplatin and were followed up the hearing test at least 2 sequential times.

Exclusion Criteria

Patients who had anatomical defect of ear and renal dysfunction before treatment.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of ototoxicity pre- or within 1 month of initiation of cisplatin and were followed up the hearing test at least 2 sequential times the Common Terminology Criteria for Adverse Events version 5

Secondary Outcome Measures

Name	Time	Method
Incidence of ototoxicity pre- or within 1 month of initiation of cisplatin and were followed up the hearing test at least 2 sequential times percent