Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention of Cisplatin-Induced Ototoxicity by Intratympanic Dexamethasone

Conditions
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Malignant Neoplasm, Ototoxicity

Intervention / Treatment
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* Drug: Dexamethasone
* Other: Placebo
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (intratympanic dexamethasone)<br>Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. Cisplatin standard of care treatment. | Drug: Dexamethasone<br>* Given via intratympanic injection<br>* Other names: DM;Other: Placebo<br>* Given via intratympanic injection<br>* Other names: PLCB;Drug: Cisplatin<br>* Standard of care treatment with the following treatment course criteria: Dose: > 50 mg/m2 Frequency: q3 -q4 weeks Cycles: 7 maximum<br>* Other names: Platinol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to up to 3 months after completion of cisplatin treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 3 months after completion of cisplatin treatment |