Platinum-based chemotherapy for sarcoma or testicular cancer Cancer Malignant neoplasm of testis
Conditions
Interventions
Tablet-based self-administered audiometry (TBSA) and distortion product otoacoustic emissions (DPOAE) will be conducted in a quiet room at the hospital. Ambient noise levels in the room will be record
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in pure-tone and high-frequency hearing levels measured using TBSA from baseline to scheduled study visits at the day before and at day 3 of each chemotherapy cycle and at a final visit 2-4 weeks after the final cycle 2. Changes in distortion product otoacoustic emissions (DPOAE) measured with handheld OAE device, Otoport Flexi OAE, from baseline to scheduled study visits at the day before and at day 3 of each chemotherapy cycle and at a final visit 2-4 weeks after the final cycle 3. Changes in hearing-related quality of life (QoL) measured with the HEAR-QL and Tinnitus Functional Index (TFI) at baseline, pre- and post-cycle (if participant reports a history of tinnitus within 2 weeks of visit), and at a final visit 2-4 weeks after the final cycle. Please note TFI is only measured in adults. There is no equivalent for children and adolescents, therefore will not be measured in this age group 4. For sarcoma patients only, serum prestin and otolin-1 levels measured in blood samples taken at baseline, pre- and post-cycle and at a final visit 2-4 weeks after the final cycle | — |
Countries
England, United Kingdom
Outcome results
None listed