Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Squamous Cell Carcinoma: A Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Tinnitus
研究概览
简要总结
The goal of this observational study is to learn about the occurrence of and to identify suitable strategies for screening and monitoring of inner ear damage in patients receiving cisplatin chemoradiotherapy for head and neck cancer. Researchers will compare patients who are receiving cisplatin chemoradiotherapy to patients who are only receiving radiotherapy. Patients will undergo standardized testing for hearing loss, tinnitus and vestibular dysfunction at baseline, during and after treatment. Optional genetic analyses will aim to identify genes known to predispose to cisplatin-induced ototoxicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of head and neck squamous cell carcinoma
- •Cisplatin-based chemoradiotherapy (monotherapy or combination-therapy, adjuvant or neo-adjuvant) or only radiotherapy (control group)
- •Age 18 to 85 years
- •Signed agreement and willingness to participate in the study and adhere to the study protocol
排除标准
- •Severe hearing impairment (WHO grade 3 or 4, corresponding to an audiometric ISO value of ≥61 dB in the better ear at frequencies of 500, 1000, 2000 and 4000 Hz)
- •Self-reported tinnitus or vestibular dysfunction in the last 3 months (only lead to exclusion of the corresponding secondary objectives, not to complete exclusion from the study)
- •Current cochlear implant
- •Concurrent treatment with loop diuretics (e.g. furosemide), aminoglycoside antibiotics or other known ototoxic substances in the last three months
- •Acute psychosis or serious psychiatric illness
- •Addiction disorder
结局指标
主要结局
Tinnitus
时间窗: From enrollment prior to treatment initiation to the last follow-up circa 3 months after completion of treatment.
Incidence and severity of new or exacerbated tinnitus during treatment with cisplatin chemotherapy measured as impairment according to the Tinnitus Handicap Inventory (THI) score: 0-16 = no impairment. 18-36 = mild impairment. 38-56 = moderate impairment. 58-76 = severe impairment. 78-100 = catastrophic impairment.
Hearing loss
时间窗: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.
Incidence of significant hearing loss during treatment with cisplatin chemotherapy described according to CTCAE (Common Terminology Criteria for Adverse Events) in 1-8 kHz audiogram: Grade 1 = threshold shift 15-25 dB in 2 contiguous test frequencies in at least one ear. Grade 2 = threshold shift \>25 dB in 2 contiguous test frequencies in at least one ear. Grade 3 = threshold shift of \>25 dB averaged at 3 contiguous test frequencies in at least one ear. Grade 4 = decrease in hearing to profound bilateral loss, absolute threshold \>80 dB at 2 kHz and above.
Vestibular dysfunction
时间窗: From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.
Incidence of dizziness or balance disturbances during treatment with cisplatin chemotherapy as determined through the Dizziness Handicap Inventory (DHI); changes of \>18 indicates a clinical relevant worsening in condition: 0-29 = no to mild impairment. 30-60 = moderate impairment. \>60 = severe impairment.
次要结局
- Description of hearing loss through further testing(From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.)
- Description of vestibular damage manifesting as worsening dizzyness or imbalance during treatment with cisplatin(From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.)
- Description of the incidence and type of cisplatin dose-limiting toxicities(From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.)
- Assessment of tumour-related quality of life(From enrollment prior to treatment initiation to the last follow-up circa 3 months after treatment completion.)
研究者
Simon Jäger
Head: Institute of Clinical Pharmacology
Paracelsus Medical University