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Clinical Trials/ISRCTN12426682
ISRCTN12426682Active, 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 enrollmentStarted: April 6, 2022Last updated:
Conditions

Trial Snapshot

Phase
未知
Status
Active, not recruiting
Sponsor
Enrollment
23

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Sex
All

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

Investigators

Sponsor
niversity College London

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