Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT02382068
Status:
WITHDRAWN
Last Update Posted:
2017-11-09
First Post:
2015-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin
Sponsor:
Aaron Moberly
Organization:
Study Overview
Official Title:
Prevention of Cisplatin-Induced Ototoxicity by Intratympanic Dexamethasone
Status:
WITHDRAWN
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patients were enrolled to trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-01247 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |