Evaluation of effect injection of diltiazem into middle ear on the hearing loss due to Cisplati

Phase 3

Recruiting

• Conditions: Hearing Loss.; Ototoxic hearing loss

• Registration Number: IRCT20081202001483N4
• Lead Sponsor: Rasht University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 October 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Age over 18 years old
Presence of Acoustic Reflex or Tympanometry A
In PTA, average hearing threshold at frequencies of 3000-5000 or 8000 to 4000 less than 40 dB
In PTA, the hearing threshold on either side should not be asymetric within 3000 to 5000 or 8000-4000 Hz frequencies or there is less than 10 dB
The karnofsky index is equal to or greater than 70

Exclusion Criteria

History of previous internal ear disease that may reduce the sensory nervous system hearing
History of Meniere's disease Or fluticating hearing loss
Observing pathologic findings in otoscopy
Previously cisplatin has not been treated
Radiation History to the head and neck Area
Candidate for radiation to the head and neck
Liver and Renal failure
Conductive hearing loss more than 5 dB
Heart problems, such as hypotension or AV block

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hearing Loss. Timepoint: One week and one month after the last dose of cisplatin. Method of measurement: Audiometry Test.;Low-frequency Average hearing threshold. Timepoint: One week and one month after the last dose of cisplatin. Method of measurement: Audiometry Test.;High-frequency Average hearing threshold. Timepoint: One week and one month after the last dose of cisplatin. Method of measurement: Audiometry Test.

Secondary Outcome Measures

Name	Time	Method
Ototoxicity Grade. Timepoint: One week and one month after the last dose of cisplatin. Method of measurement: Audiometry( Grade changes).;Complications of cisplatin injection. Timepoint: One week and one month after the last dose of cisplatin. Method of measurement: Questions From Patient.