Monitoring hearing in patients undergoing platinum-based chemotherapy

Not Applicable

• Conditions: Platinum-based chemotherapy for sarcoma or testicular cancer; Cancer; Malignant neoplasm of testis

• Registration Number: ISRCTN12426682
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-06
• Last Update Posted: 27 February 2024
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients that are compliant with the planned tablet-based self-administered audiometry schedule measured at each scheduled study visit (i.e., baseline, pre-cycle, and post-cycle and at a final visit 2-4 weeks after their final cycle)