WithdrawnNot Applicable

Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

Stopped: No patients were enrolled to trial

0Started 2014-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in score of pure tone audiometry of conventional and high-frequency ranges (hearing level decibels [dB] hearing level)

Timeframe: Baseline to up to 3 months after completion of cisplatin treatment

Trial details

NCT IDNCT02382068

SponsorAaron Moberly

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07

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