Back to resultsDexamethasone 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Withdrawn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
About this trial
This is an interventional supportive care trial for Malignant Neoplasm
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
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
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
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