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Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

Sponsor
Aaron Moberly (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02382068
Collaborator
(none)
0
Enrollment
1
Arm
35
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Prevention of Cisplatin-Induced Ototoxicity by Intratympanic Dexamethasone
Anticipated Study Start Date :
Aug 1, 2014
Anticipated Primary Completion Date :
Jul 1, 2017
Anticipated Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Dexamethasone
Given via intratympanic injection
Other Names:
  • DM

    • Other: Placebo
    Given via intratympanic injection
    Other Names:
  • PLCB

    • Drug: Cisplatin
    Standard of care treatment with the following treatment course criteria: Dose: > 50 mg/m2 Frequency: q3 -q4 weeks Cycles: 7 maximum
    Other Names:
  • Platinol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in score of pure tone audiometry of conventional and high-frequency ranges (hearing level decibels [dB] hearing level) [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.

    Secondary Outcome Measures

    1. Change in score of distortion product otoacoustic emissions of conventional and high-frequency ranges (amplitude dB sound pressure level) [Baseline to up to 3 months after completion of cisplatin treatment]

      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.

    2. Presence of ototoxicity as defined by the American Speech-Language Hearing Association (ASHA) [Up to 3 months after completion of cisplatin treatment]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Aaron Moberly

    Investigators

    • Principal Investigator: Aaron Moberly, MD, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Aaron Moberly, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02382068
    Other Study ID Numbers:
    • OSU-12003
    • NCI-2014-01247
    First Posted:
    Mar 6, 2015
    Last Update Posted:
    Nov 9, 2017
    Last Verified:
    Nov 1, 2017
    Additional relevant MeSH terms:
    Neoplasms
    Ototoxicity
    Dexamethasone

    Study Results

    No Results Posted as of Nov 9, 2017