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

Comparison of cisplatin otoprotection using intratympanic diltiazem and placebo among patients with solid cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20081202001483N4
Enrollment
25
Registered
2018-09-16
Start date
2018-09-23
Completion date
Unknown
Last updated
2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss. Ototoxic hearing loss

Interventions

Intervention 1: Intervention group: At first, Case-ear is filled with Xyla-P ointment. After 5 minute local anesthesia , ointment was suctioned under microscope. 0.7-1 cc of Diltiazem solution (5mg/ml

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Secondary

MeasureTime frame
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.

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mirmohammad Jalali

Iran University of Medical Sciences

mmjalali@gmail.com+98 13 3322 5242

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026