search
Back to results

Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

Primary Purpose

Malignant Neoplasm, Ototoxicity

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Cisplatin
Sponsored by
Aaron Moberly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Supportive care (intratympanic dexamethasone)

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    February 16, 2015
    Last Updated
    November 7, 2017
    Sponsor
    Aaron Moberly
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02382068
    Brief Title
    Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin
    Official Title
    Prevention of Cisplatin-Induced Ototoxicity by Intratympanic Dexamethasone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No patients were enrolled to trial
    Study Start Date
    August 2014 (Anticipated)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Aaron Moberly

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malignant Neoplasm, Ototoxicity

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supportive care (intratympanic dexamethasone)
    Arm Type
    Experimental
    Arm Description
    Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. Cisplatin standard of care treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Other Intervention Name(s)
    DM
    Intervention Description
    Given via intratympanic injection
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    PLCB
    Intervention Description
    Given via intratympanic injection
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Other Intervention Name(s)
    Platinol
    Intervention Description
    Standard of care treatment with the following treatment course criteria: Dose: > 50 mg/m2 Frequency: q3 -q4 weeks Cycles: 7 maximum
    Primary Outcome Measure Information:
    Title
    Change in score of pure tone audiometry of conventional and high-frequency ranges (hearing level decibels [dB] hearing level)
    Description
    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.
    Time Frame
    Baseline to up to 3 months after completion of cisplatin treatment
    Secondary Outcome Measure Information:
    Title
    Change in score of distortion product otoacoustic emissions of conventional and high-frequency ranges (amplitude dB sound pressure level)
    Description
    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.
    Time Frame
    Baseline to up to 3 months after completion of cisplatin treatment
    Title
    Presence of ototoxicity as defined by the American Speech-Language Hearing Association (ASHA)
    Description
    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.
    Time Frame
    Up to 3 months after completion of cisplatin treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aaron Moberly, MD
    Organizational Affiliation
    Ohio State University Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://cancer.osu.edu
    Description
    The Jamesline

    Learn more about this trial

    Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

    We'll reach out to this number within 24 hrs