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Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

NCT ID: NCT02382068

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-07-31

Brief Summary

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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

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PRIMARY OBJECTIVES:

I. 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

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Malignant Neoplasm Ototoxicity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (intratympanic dexamethasone)

Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. Cisplatin standard of care treatment.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Given via intratympanic injection

Placebo

Intervention Type OTHER

Given via intratympanic injection

Cisplatin

Intervention Type DRUG

Standard of care treatment with the following treatment course criteria:

1. Dose: \> 50 mg/m2
2. Frequency: q3 -q4 weeks
3. Cycles: 7 maximum

Interventions

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Dexamethasone

Given via intratympanic injection

Intervention Type DRUG

Placebo

Given via intratympanic injection

Intervention Type OTHER

Cisplatin

Standard of care treatment with the following treatment course criteria:

1. Dose: \> 50 mg/m2
2. Frequency: q3 -q4 weeks
3. Cycles: 7 maximum

Intervention Type DRUG

Other Intervention Names

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DM PLCB Platinol

Eligibility Criteria

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Inclusion Criteria

* Planned cisplatin treatment restricted to the following treatment course criteria:

* Dose: \> 50 mg/m\^2
* Frequency: every (q)3-q4 weeks
* Cycles: 7 maximum

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aaron Moberly

OTHER

Sponsor Role lead

Responsible Party

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Aaron Moberly

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Aaron Moberly, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Countries

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United States

Related Links

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http://cancer.osu.edu

The Jamesline

Other Identifiers

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NCI-2014-01247

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-12003

Identifier Type: -

Identifier Source: org_study_id