Overview

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Withdrawn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