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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Given via intratympanic injection
Given via intratympanic injection
Standard of care treatment with the following treatment course criteria: 1. Dose: \> 50 mg/m2 2. Frequency: q3 -q4 weeks 3. Cycles: 7 maximum
Change in score of pure tone audiometry of conventional and high-frequency ranges (hearing level decibels [dB] hearing level)
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.
Time frame: Baseline to up to 3 months after completion of cisplatin treatment
Change in score of distortion product otoacoustic emissions of conventional and high-frequency ranges (amplitude dB sound pressure level)
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.
Time frame: Baseline to up to 3 months after completion of cisplatin treatment
Presence of ototoxicity as defined by the American Speech-Language Hearing Association (ASHA)
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.
Time frame: Up to 3 months after completion of cisplatin treatment
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