Intratympanic Steroid Treatment For The Prevention Of Inn... | NCT01285674

Studies
Intratympanic Steroid Treatment For The Prevention Of Inner Ear Toxicity Associated With Systemic Treatment With Cisplatin.

NCT01285674

Sponsor

Ziv Hospital

Status

Unknown status

Last Update Posted

Jan 28, 2011Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Cisplatin
Ototoxicity
Intratympanic Steroids

Interventions

Intra-tympanic Cisplatinum

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2012Estimated

Completion Date

Jan 2012Estimated

First Submitted Date

Jan 23, 2011

First Submission Date that Met QC Criteria

Jan 27, 2011

First Posted Date

Jan 28, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2011

Last Update Posted Date

Jan 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.

Detailed Description

Cisplatin is a potent and widely used antineoplastic drug. Ototoxicity is a serious and dose-limiting side effect. The ototoxic effect of cisplatin is characterized by irreversible, progressive, bilateral, high-frequency, sensorineural hearing loss with tinnitus. 60-80% of patients treated show elevations of hearing thresholds and nearly 15% sustain significant hearing handicap. There are currently no clinical interventions that have been shown to prevent cisplatin ototoxicity in humans. Glucocorticoids have significant potential for otoprotection. Glucocorticoids are in use for treatment of a variety of cochlear disorders such as autoimmune inner ear disease, Meniere's disease and sudden sensorineural hearing loss. Intratympanic administration of drugs is a contemporary, safe method of locally treating inner ear disorders, allowing diffusion across the round window into the inner ear. This method achieves much higher steroid levels within the inner ear compared to oral or parenteral routes. Local administration prevents the common systemic side effects of steroids. Previous animal studies have shown protection against cisplatin-induced ototoxicity after intratympanic steroid injection. Asa far as we know, there are yet no studies in humans examining the otoprotective effect of intratympanic steroids in patients treated with cisplatin. In this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intra-tympanic steroid injection	Experimental		Drug: Intra-tympanic Cisplatinum

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intra-tympanic Cisplatinum	Drug	Intra-tympanic injection (under local anesthesia) of 0.5cc Methylprednisolone 62.5mg/cc. One injection per ear before each of the 3 cisplatin treatments. After injection the patient will remain with the treated ear upwards for 20 minutes and will try to avoid swallowing as much as possible.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-Treatment change in hearing	change in hearing as a result of cisplatin treatment as assessed by behavioural hearing test and otoacoustic emissions	approximately 1 month from 1st treatment

Secondary Outcomes

Measure	Description	Time Frame
Tinnitus	appearence or worsening of tinnitus as a result of cisplatin treatment	1 month post-treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults 18 years old at least who are candidates for Cisplatin treatment
agreement to participate in the study
have signed an informed consent.

Exclusion Criteria:

refusal to participate
steroid treatment during the past month
external or middle ear disease not enabling intratympanic treatment
inner ear disease causing hearing loss
severe hearing loss for any reason
conductive hearing loss

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Gilbey, MD	Contact	972-50-8434014		peter.g@ziv.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ziv Medical Center		Safed		13100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D000081015	Ototoxicity

Ancestor Terms

ID	Term
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided