NCT01285674

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 28, 2011

Status Verified

January 1, 2011

Enrollment Period

1 year

First QC Date

January 23, 2011

Last Update Submit

January 27, 2011

Conditions

CisplatinOtotoxicityIntratympanic Steroids

Keywords

cisplatinototoxicityintratympanic steroids

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Tinnitus

    1 month post-treatment

Study Arms (1)

Intra-tympanic steroid injection

EXPERIMENTAL
Drug: Intra-tympanic Cisplatinum

Interventions

Intra-tympanic CisplatinumDRUG

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.

Intra-tympanic steroid injection

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziv Medical Center

Safed, 13100, Israel

Location

MeSH Terms

Conditions

Ototoxicity

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Central Study Contacts

Peter Gilbey, MD

CONTACT

972-50-8434014peter.g@ziv.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 23, 2011

First Posted

January 28, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 28, 2011

Record last verified: 2011-01

Locations

IL(1)