Prevention of Cisplatin-Induced Ototoxicity by Intratympanic Dexamethasone
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change in score of pure tone audiometry of conventional and high-frequency ranges (hearing level decibels [dB] hearing level)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned cisplatin treatment restricted to the following treatment course criteria:
- •Dose: > 50 mg/m^2
- •Frequency: every (q)3-q4 weeks
- •Cycles: 7 maximum
排除标准
- •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
研究组 & 干预措施
Supportive care (intratympanic dexamethasone)
Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. Cisplatin standard of care treatment.
干预措施: Dexamethasone (Drug)
Supportive care (intratympanic dexamethasone)
Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. Cisplatin standard of care treatment.
干预措施: Placebo (Other)
Supportive care (intratympanic dexamethasone)
Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. Cisplatin standard of care treatment.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Change in score of pure tone audiometry of conventional and high-frequency ranges (hearing level decibels [dB] hearing level)
时间窗: Baseline to up to 3 months after completion of cisplatin treatment
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.
次要结局
- Presence of ototoxicity as defined by the American Speech-Language Hearing Association (ASHA)(Up to 3 months after completion of cisplatin treatment)
- 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)
研究者
Aaron Moberly
Principal Investigator
Ohio State University Comprehensive Cancer Center