Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

Not Applicable

Withdrawn

• Conditions: Malignant Neoplasm; Ototoxicity
• Interventions: Drug: Dexamethasone; Other: Placebo; Drug: Cisplatin

• Registration Number: NCT02382068
• Lead Sponsor: Aaron Moberly

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-02-16
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-06
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (intratympanic dexamethasone)	Dexamethasone	Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. Cisplatin standard of care treatment.
Supportive care (intratympanic dexamethasone)	Placebo	Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. Cisplatin standard of care treatment.
Supportive care (intratympanic dexamethasone)	Cisplatin	Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. Cisplatin standard of care treatment.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.