Malignant Neoplasm, Ototoxicity
Conditions
Brief summary
This randomized pilot clinical trial studies dexamethasone in preventing hearing loss in patients receiving cisplatin. Injecting a steroid, such as dexamethasone, behind the eardrum before chemotherapy may help protect against cisplatin-associated hearing loss.
Detailed description
PRIMARY OBJECTIVES: I. Investigate the potential protective effect of intratympanic dexamethasone administration on cisplatin-induced ototoxicity. OUTLINE: Patients are randomized as to which ear receives dexamethasone. Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. After completion of study treatment, patients are followed up before each cisplatin treatment and then at 1 and 3 months after the last cisplatin treatment.
Interventions
DRUGDexamethasone
Given via intratympanic injection
OTHERPlacebo
Given via intratympanic injection
DRUGCisplatin
Standard of care treatment with the following treatment course criteria: 1. Dose: \> 50 mg/m2 2. Frequency: q3 -q4 weeks 3. Cycles: 7 maximum
Sponsors
Aaron Moberly
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned cisplatin treatment restricted to the following treatment course criteria: * Dose: \> 50 mg/m\^2 * Frequency: every (q)3-q4 weeks * Cycles: 7 maximum
Exclusion criteria
* Previous cisplatin treatment * Previous or concurrent radiation treatment to the head and neck region * Previous or existing pathology of the external or middle ear which would preclude auditory testing and/or intratympanic dexamethasone delivery * Previous or existing pathology of the inner ear with or without hearing loss (i.e. sudden sensorineural hearing loss, Meniere's disease, autoimmune inner ear disease) * Previous or existing pathology of the central nervous system with potential to impact auditory pathways (i.e. major head trauma, meningitis, encephalitis, brain metastasis, vestibular schwannoma) * Recent steroid treatment within the last month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in score of pure tone audiometry of conventional and high-frequency ranges (hearing level decibels [dB] hearing level) | Baseline to up to 3 months after completion of cisplatin treatment | Change score will be assessed comparing baseline testing (prior to first cisplatin treatment) and various monitoring intervals (prior to each successive cisplatin treatment and 1 month and 3 months following completion of cisplatin treatment). Analyzed using a repeated measures model and a multi-level model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in score of distortion product otoacoustic emissions of conventional and high-frequency ranges (amplitude dB sound pressure level) | Baseline to up to 3 months after completion of cisplatin treatment | Will be assessed comparing baseline testing (prior to first cisplatin treatment) and various monitoring intervals (prior to each successive cisplatin treatment and 1 months and 3 months following completion of cisplatin treatment). Analyzed using a repeated measures model and a multi-level model. |
| Presence of ototoxicity as defined by the American Speech-Language Hearing Association (ASHA) | Up to 3 months after completion of cisplatin treatment | Presence or absence of ototoxicity as defined by the ASHA standards for pure tone audiometry (20 dB or greater change at any one test frequency, 10 dB or greater change at any two test frequencies, or any change at any three test frequencies). Analyzed using a repeated measures model and a multi-level model. |
Outcome results
None listed