Skip to main content
Clinical Trials/ISRCTN12426682
ISRCTN12426682
Active, not recruiting
未知

Monitoring ototoxicity in patients undergoing treatment with platinum-based chemotherapy for sarcoma and testicular cancer using tablet-based self-administered audiometry and serum biomarkers

niversity College London0 sites23 target enrollmentApril 6, 2022

Overview

Phase
未知
Intervention
Not specified
Conditions
Platinum-based chemotherapy for sarcoma or testicular cancer
Sponsor
niversity College London
Enrollment
23
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 6, 2022
End Date
April 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
niversity College London

Eligibility Criteria

Inclusion Criteria

  • 1\. Patients diagnosed with sarcoma (male or female) or testicular cancer (male) and selected for platinum\-based chemotherapy
  • 2\. Aged between 13 and 40 years
  • 3\. Able to provide informed consent
  • 4\. Able to understand and cope with the use of headphones and self\-administered hearing assessments (as assessed by the researcher at informed consent)
  • 5\. No recent history of ear disease, e.g., acute otitis media, otitis media with effusion, middle ear surgery
  • 6\. Hearing at screening better than 40 dB across the following frequencies: 0\.25, 0\.5, 1, 2, 4 and 8 kHz

Exclusion Criteria

  • 1\. Prior platinum\-based chemotherapy within 5 years prior to study cycle 1, day 1
  • 2\. Abnormalities of the external or middle ear revealed by otoscopy at screening: otitis externa, otitis media, visible tympanic membrane perforation
  • 3\. Conductive hearing loss, a ‘true’ air\-bone gap \=15 dB HL in three or more contiguous frequencies between 0\.5, 1, 2, 4 kHz

Outcomes

Primary Outcomes

Not specified

Similar Trials