Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT02382068
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02382068
Study Brief:
Protocol Section:
NCT02382068