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.
Investigators
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
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