Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

Malignant Neoplasm Clinical Trial

Official title:

Prevention of Cisplatin-Induced Ototoxicity by Intratympanic Dexamethasone

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02382068
• Other study ID #: OSU-12003
• Secondary ID: NCI-2014-01247
• Status: Withdrawn
• Phase: N/A
• First received: February 16, 2015
• Last updated: November 7, 2017
• Start date: August 2014
• Est. completion date: July 2017

Study information

• Verified date: November 2017
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms
• Ototoxicity

Intervention

Drug:
• Dexamethasone
Given via intratympanic injection

Other:
• Placebo
Given via intratympanic injection

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aaron Moberly

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to up to 3 months after completion of cisplatin treatment
Secondary	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.	Baseline to up to 3 months after completion of cisplatin treatment
Secondary	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.	Up to 3 months after completion of cisplatin treatment

External Links

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