Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

• Status: Withdrawn
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aaron Moberly
• Treatments: BB 1101; Cisplatin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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