CisplatinNCT01285674
Intratympanic Steroid Treatment For The Prevention Of Inner Ear Toxicity Associated With Systemic Treatment With Cisplatin.
A study testing Intra-tympanic Cisplatinum in people with Cisplatin and Ototoxicity, run by Ziv Hospital at 1 site in Israel.
Trial summary
In this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cisplatin, Ototoxicity, Intratympanic Steroids
- What is being tested?
- Intra-tympanic Cisplatinum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults 18 years old at least who are candidates for Cisplatin treatment
- agreement to participate in the study
- have signed an informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ziv Medical Center
Safed, 13100
Peter Gilbey, MD, 972-50-8434014, peter.g@ziv.health.gov.il
Peter Gilbey, MD
About this study
Official title: INTRATYMPANIC STEROID TREATMENT FOR THE PREVENTION OF INNER EAR TOXICITY ASSOCIATED WITH SYSTEMIC TREATMENT WITH CISPLATIN.
In this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.
Read the 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.
- Conditions
- Cisplatin, Ototoxicity, Intratympanic Steroids
- Being tested
- Intra-tympanic Cisplatinum
- Keywords
- cisplatin, ototoxicity, intratympanic steroids
- Medical subject headings
- Ototoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intra-tympanic steroid injection | Experimental | Not described Receives: Drug: Intra-tympanic Cisplatinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Treatment change in hearing
change in hearing as a result of cisplatin treatment as assessed by behavioural hearing test and otoacoustic emissions
Measured: approximately 1 month from 1st treatment
Secondary outcomes (1)
Tinnitus
appearence or worsening of tinnitus as a result of cisplatin treatment
Measured: 1 month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CisplatinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285674
- Sponsor's protocol ID
- 0035-10-ZIV
- Status last verified
- Jan 2011
- First submitted
- 23 Jan 2011
- Last updated
- 28 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTRATYMPANIC STEROID TREATMENT FOR THE PREVENTION OF INNER EAR TOXICITY ASSOCIATED WITH SYSTEMIC TREATMENT WITH CISPLATIN.
- ClinicalTrials.gov ID
- NCT01285674
- Acronym / sponsor ID
- 0035-10-ZIV
- Conditions
- Cisplatin, Ototoxicity, Intratympanic Steroids
- Keywords
- cisplatin, ototoxicity, intratympanic steroids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 28 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-tympanic steroid injection | Experimental | Drug: Intra-tympanic Cisplatinum |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults 18 years old at least who are candidates for Cisplatin treatment
- agreement to participate in the study
- have signed an informed consent.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-tympanic CisplatinumIntra-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. | Drug | Intra-tympanic steroid injection |
Primary outcome
Post-Treatment change in hearing
Time frame: approximately 1 month from 1st treatment
change in hearing as a result of cisplatin treatment as assessed by behavioural hearing test and otoacoustic emissions
1 secondary outcome
Tinnitus
Time frame: 1 month post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-tympanic Cisplatinum in people with Cisplatin and Ototoxicity, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Gilbey, MD (972-50-8434014, peter.g@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Treatment change in hearing (time frame: approximately 1 month from 1st treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2011.