Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

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.

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