Malignant NeoplasmNCT02382068
Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin
A study testing Dexamethasone and Cisplatin in people with Malignant Neoplasm and Ototoxicity, run by Aaron Moberly.
Trial summary
This randomized pilot clinical trial studies dexamethasone in preventing hearing loss in patients receiving cisplatin. Injecting a steroid, such as dexamethasone, behind the eardrum before chemotherapy may help protect against cisplatin-associated hearing loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm, Ototoxicity
- What is being tested?
- Dexamethasone and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Jul 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned cisplatin treatment restricted to the following treatment course criteria:
- Dose: > 50 mg/m^2
- Frequency: every (q)3-q4 weeks
- Cycles: 7 maximum
Who cannot join
- Previous cisplatin treatment
- Previous or concurrent radiation treatment to the head and neck region
- Previous or existing pathology of the external or middle ear which would preclude auditory testing and/or intratympanic dexamethasone delivery
- Previous or existing pathology of the inner ear with or without hearing loss (i.e. sudden sensorineural hearing loss, Meniere's disease, autoimmune inner ear disease)
- Previous or existing pathology of the central nervous system with potential to impact auditory pathways (i.e. major head trauma, meningitis, encephalitis, brain metastasis, vestibular schwannoma)
- Recent steroid treatment within the last month
About this study
Official title: Prevention of Cisplatin-Induced Ototoxicity by Intratympanic Dexamethasone
This randomized pilot clinical trial studies dexamethasone in preventing hearing loss in patients receiving cisplatin. Injecting a steroid, such as dexamethasone, behind the eardrum before chemotherapy may help protect against cisplatin-associated hearing loss.
Read the detailed description
PRIMARY OBJECTIVES:
- Investigate the potential protective effect of intratympanic dexamethasone administration on cisplatin-induced ototoxicity.
OUTLINE: Patients are randomized as to which ear receives dexamethasone.
Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear.
After completion of study treatment, patients are followed up before each cisplatin treatment and then at 1 and 3 months after the last cisplatin treatment.
- Conditions
- Malignant Neoplasm, Ototoxicity
- Being tested
- Dexamethasone, Placebo, Cisplatin
- Medical subject headings
- Neoplasms, Ototoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called DM
Given via intratympanic injection
PlaceboOther
Also called PLCB
Given via intratympanic injection
CisplatinDrug
Also called Platinol
Standard of care treatment with the following treatment course criteria:
- Dose: > 50 mg/m2
- Frequency: q3 -q4 weeks
- Cycles: 7 maximum
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (intratympanic dexamethasone) | Experimental | Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. Cisplatin standard of care treatment. Receives: Drug: Dexamethasone; Other: Placebo; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score of pure tone audiometry of conventional and high-frequency ranges (hearing level decibels [dB] hearing level)
Change score will be assessed comparing baseline testing (prior to first cisplatin treatment) and various monitoring intervals (prior to each successive cisplatin treatment and 1 month and 3 months following completion of cisplatin treatment). Analyzed using a repeated measures model and a multi-level model.
Measured: Baseline to up to 3 months after completion of cisplatin treatment
Secondary outcomes (2)
Change in score of distortion product otoacoustic emissions of conventional and high-frequency ranges (amplitude dB sound pressure level)
Will be assessed comparing baseline testing (prior to first cisplatin treatment) and various monitoring intervals (prior to each successive cisplatin treatment and 1 months and 3 months following completion of cisplatin treatment). Analyzed using a repeated measures model and a multi-level model.
Measured: Baseline to up to 3 months after completion of cisplatin treatment
Presence of ototoxicity as defined by the American Speech-Language Hearing Association (ASHA)
Presence or absence of ototoxicity as defined by the ASHA standards for pure tone audiometry (20 dB or greater change at any one test frequency, 10 dB or greater change at any two test frequencies, or any change at any three test frequencies). Analyzed using a repeated measures model and a multi-level model.
Measured: Up to 3 months after completion of cisplatin treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startAug 2014 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Why it stopped: No patients were enrolled to trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aaron Moberly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aaron Moberly, Ohio State University Comprehensive Cancer Center
- Investigators
- Aaron Moberly, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382068
- Sponsor's protocol ID
- OSU-12003
- Other IDs
- NCI-2014-01247
- Status last verified
- Nov 2017
- First submitted
- 16 Feb 2015
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Cisplatin-Induced Ototoxicity by Intratympanic Dexamethasone
- ClinicalTrials.gov ID
- NCT02382068
- Acronym / sponsor ID
- OSU-12003
- Conditions
- Malignant Neoplasm, Ototoxicity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients were enrolled to trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aaron MoberlyUniversity, hospital or other
- Study start
- Aug 2014 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 6 Mar 2015 (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.
This randomized pilot clinical trial studies dexamethasone in preventing hearing loss in patients receiving cisplatin. Injecting a steroid, such as dexamethasone, behind the eardrum before chemotherapy may help protect against cisplatin-associated hearing loss.
Detailed description
PRIMARY OBJECTIVES:
- Investigate the potential protective effect of intratympanic dexamethasone administration on cisplatin-induced ototoxicity.
OUTLINE: Patients are randomized as to which ear receives dexamethasone.
Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear.
After completion of study treatment, patients are followed up before each cisplatin treatment and then at 1 and 3 months after the last cisplatin treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (intratympanic dexamethasone) | Experimental | Drug: Dexamethasone, Other: Placebo, Drug: CisplatinPatients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. Cisplatin standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned cisplatin treatment restricted to the following treatment course criteria:
Key exclusion criteria (6 listed)
- Previous cisplatin treatment
- Previous or concurrent radiation treatment to the head and neck region
- Previous or existing pathology of the external or middle ear which would preclude auditory testing and/or intratympanic dexamethasone delivery
- Previous or existing pathology of the inner ear with or without hearing loss (i.e. sudden sensorineural hearing loss, Meniere's disease, autoimmune inner ear disease)
- Previous or existing pathology of the central nervous system with potential to impact auditory pathways (i.e. major head trauma, meningitis, encephalitis, brain metastasis, vestibular schwannoma)
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 |
|---|---|---|
| DexamethasoneAlso: DMGiven via intratympanic injection | Drug | Supportive care (intratympanic dexamethasone) |
| PlaceboAlso: PLCBGiven via intratympanic injection | Other | Supportive care (intratympanic dexamethasone) |
| CisplatinAlso: PlatinolStandard of care treatment with the following treatment course criteria: 1. Dose: > 50 mg/m2 2. Frequency: q3 -q4 weeks 3. Cycles: 7 maximum | Drug | Supportive care (intratympanic dexamethasone) |
Primary outcome
Change in score of pure tone audiometry of conventional and high-frequency ranges (hearing level decibels [dB] hearing level)
Time frame: Baseline to up to 3 months after completion of cisplatin treatment
Change score will be assessed comparing baseline testing (prior to first cisplatin treatment) and various monitoring intervals (prior to each successive cisplatin treatment and 1 month and 3 months following completion of cisplatin treatment). Analyzed using a repeated measures model and a multi-level model.
2 secondary outcomes
Change in score of distortion product otoacoustic emissions of conventional and high-frequency ranges (amplitude dB sound pressure level)
Time frame: Baseline to up to 3 months after completion of cisplatin treatment
Presence of ototoxicity as defined by the American Speech-Language Hearing Association (ASHA)
Time frame: Up to 3 months after completion of cisplatin treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- The JameslineLink provided by the sponsor.
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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.
Aaron Moberly, MD principal investigator
Ohio State University Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Cisplatin in people with Malignant Neoplasm and Ototoxicity, run by Aaron Moberly.
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 4 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: withdrawn, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score of pure tone audiometry of conventional and high-frequency ranges (hearing level decibels [dB] hearing level) (time frame: Baseline to up to 3 months after completion of cisplatin 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 9 Nov 2017.