Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

NCT02382068 | Withdrawn DMC

• 2 other identifiers: OSU-12003NCI-2014-01247
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malignant Neoplasm; Ototoxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Presence of ototoxicity as defined by the American Speech-Language Hearing Association (ASHA)

  Up to 3 months after completion of cisplatin treatment

Study Arms (1)

Supportive care (intratympanic dexamethasone)

EXPERIMENTAL

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; Other: Placebo; Drug: Cisplatin

Interventions

Dexamethasone DRUG

Given via intratympanic injection

Also known as: DM

Supportive care (intratympanic dexamethasone)

Placebo OTHER

Given via intratympanic injection

Also known as: PLCB

Supportive care (intratympanic dexamethasone)

Cisplatin DRUG

Standard of care treatment with the following treatment course criteria: 1. Dose: \> 50 mg/m2 2. Frequency: q3 -q4 weeks 3. Cycles: 7 maximum

Also known as: Platinol

Supportive care (intratympanic dexamethasone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned cisplatin treatment restricted to the following treatment course criteria:
• Dose: \> 50 mg/m\^2
• Frequency: every (q)3-q4 weeks
• Cycles: 7 maximum

You may not qualify if:

• 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

Sponsors & Collaborators

• Aaron Moberly: lead

Related Links

• The Jamesline

MeSH Terms

Conditions

Neoplasms; Ototoxicity

Interventions

Dexamethasone; Cisplatin

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Aaron Moberly, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: March 6, 2015
• Study Start: August 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11