The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Hearing-Related Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Speech perception in noise
研究概览
简要总结
The study will assess the effect of cancer treatments on speech perception in noise, cognition, and hearing-related quality of life by monitoring 200 cancer patients receiving standard care for their underlying malignancy.
详细描述
The study will assess the effects of four different types of cancer treatments on speech perception in noise, hearing thresholds, cognition, and hearing-related quality of life over a follow-up period of 3 years.
The speech perception in noise will be assessed using the Finnish matrix sentence test. Other hearing measures include transient and distortion product otoacoustic emissions, impedance audiometry and pure-tone audiometry extending to high frequencies (0.125kHz - 16kHz).
Hearing-related quality of life will be assessed using Speech, Spatial, and Qualities 12 -questionnaire, Vanderbilt Fatigue Scale 10 -questionnaire and Tinnitus Handicap Index. Cognitive functions will be assed using Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) questionnaire and neuropsychological tests. The neuropsychological tests included in the study are Continuous Performance Test, Continuous Auditory Test of Attention, Trail Making Test A & B, Stroop Test, Coding and Digit span tasks from the Wechsler Adult Intelligence Scale - Fourth Edition, Word List task from Wechsler Memory Scale III, and Controlled Oral Word Association Test.
Neuropsychological assessments will be conducted at baseline and 1 year and 3 years after the end of the treatments. All other assessments will be conducted at baseline and at 3-4 months, 1 year, and 3 years after the end of the initial treatments.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent
- •native Finnish speaker
- •age-normative hearing
- •for participants in the treatment arms: diagnosis of a malignancy that will be treated with curative intent with any of the following: 1) Cisplatin as the main chemotherapeutic agent, 2) oxaliplatin as the main chemotherapeutic agent, 3) cisplatin-based chemoradiation therapy in the head and neck region, 4) radiation therapy in the head and neck region
排除标准
- •inability to provide written informed consent
- •Current or prior major otological condition that has affected or has had the potential to affect hearing
- •Conductive or asymmetric sensorineural HL of any severity
- •Severe sensorineural HL
- •Prior malignancy treated with chemotherapeutics or radiation therapy
- •Prior use of ototoxic medications
- •Any significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk by participation in the trial, or may influence the result of the trial.
- •Any condition that, in the opinion of the investigator, would interfere with adherence to the trial requirements.
- •For participants in the treatment arms:
- •Allergy or hypersensitivity to trial medications or their ingredients
- •Pregnancy or breast-feeding, aim of becoming pregnant during the trial.
结局指标
主要结局
Speech perception in noise
时间窗: 4 months
The treatment-related change in speech perception in noise (in decibel signal-to-noise ratio (db SNR)) from baseline to first follow-up at 3-4 months after the end of the treatment.
次要结局
- Short- and long-term effects on high frequency hearing(3 years)
- Hearing-related quality of life - Tinnitus(3 years)
- Treatment-related changes in brain glucose metabolism(3 years)
- Hearing-related quality of life - Sound quality(3 years)
- Hearing-related quality of life - Fatigue(3 years)
- Long-term effects on speech perception in noise(3 years)
研究者
Tytti Willberg
Principal Investigator
Turku University Hospital