An interventional study of Intra-tympanic Cisplatinum in Cisplatin, Ototoxicity and Intratympanic Steroids, sponsored by Ziv Hospital. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2011-01-28.
Sponsored by Ziv Hospital · Not applicable, Interventional, and Prevention
In this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.
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.
49 studies on the registry are indexed under Ototoxicity; 15 are open to participants now.
This study's planned enrollment of 20 is below the median of 47 across 33 interventional studies indexed under Ototoxicity.
Browse Ototoxicity studies →Ziv Hospital is the lead sponsor of 83 studies on the registry; 3 are open to participants now.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Intra-tympanic Cisplatinum
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.
Post-Treatment change in hearing
change in hearing as a result of cisplatin treatment as assessed by behavioural hearing test and otoacoustic emissions
Time frame: approximately 1 month from 1st treatment
Tinnitus
appearence or worsening of tinnitus as a result of cisplatin treatment
Time frame: 1 month post-treatment
This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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Ziv Hospital