Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

Aaron Moberly

Status: Withdrawn

Conditions: Malignant Neoplasm; Ototoxicity

Treatments: Drug: Cisplatin; Drug: Dexamethasone; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02382068

NCI-2014-01247 (Registry Identifier)

OSU-12003

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Supportive care (intratympanic dexamethasone)

Experimental group

Description:

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

Treatment:

Drug: Cisplatin

Other: Placebo

Drug: Dexamethasone