NCT02382068

Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

Prevention of Cisplatin-Induced Ototoxicity by Intratympanic Dexamethasone

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Aaron Moberly · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Neoplasm
• Ototoxicity

Interventions

Type	Name	Description
DRUG	Dexamethasone	Given via intratympanic injection
OTHER	Placebo	Given via intratympanic injection
DRUG	Cisplatin	Standard of care treatment with the following treatment course criteria: 1. Dose: \> 50 mg/m2 2. Frequency: q3 -q4 weeks 3. Cycles: 7 maximum

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2015-03-06
• Last updated: 2017-11-09