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临床试验/NCT07553481
NCT07553481招募中不适用

Chemotherapy-Induced Hearing Loss and Health Inequality

Lancaster University2 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2026年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
172
试验地点
2
主要终点
Speech Reception Threshold in noise (Digit Triplet Test, dB Signal-to-Noise Ratio)

研究概览

简要总结

This project aims to understand how platinum-based chemotherapy affects hearing function in cancer patients from different socioeconomic backgrounds in the North West of England. Platinum-based chemotherapy drugs, such as cisplatin, are ototoxic, meaning that they cause permanent damage to the hair cells of the ear, resulting in hearing loss. Patients from more deprived backgrounds face additional risk factors to their hearing health, including limited healthcare access, greater occupational noise exposure, and poorer overall health, making them more vulnerable to hearing loss.

This is especially concerning as hearing loss can make communication more challenging, which creates a greater reliance on cognitive processes such as thinking and memory to navigate social interactions. This challenge is exacerbated when individuals experience cognitive dysfunction related to chemotherapy, commonly referred to as 'chemo brain'. Addressing these communication difficulties is crucial for promoting healthy ageing and maintaining social engagement. It is expected that cancer patients from the most deprived backgrounds would experience greater hearing loss following chemotherapy than those from less deprived backgrounds.

As a secondary aim, this study will also investigate how hearing loss may affect cognitive function. Specifically, it will assess whether differences in speech-in-noise performance from pre- to post-treatment predict cognitive performance post-treatment, to understand if changes in hearing over time are associated with changes in cognition. The study will also explore how socioeconomic deprivation, cumulative chemotherapy dose, and treatment duration influence these relationships. By identifying disparities in hearing loss and possible associations with cognition, this research will help guide future hearing screening and intervention strategies for cancer patients.

详细描述

This project will inform and guide future care for cancer patients by investigating how cancer patients are affected by chemotherapy-induced hearing loss. Platinum-based chemotherapy drugs are known to cause damage to the ear. One of the most toxic chemotherapy drugs is cisplatin, which is used to treat testicular, ovarian, lung, bladder, head & neck, oesophageal, cervical, and stomach cancers. Platinum-based chemotherapy agents cause oxidative stress and cell death in cochlear cells in the ear, which leads to permanent damage to the hearing system.

This damage presents as hearing loss, and hearing loss is not routinely screened for or detected in cancer patients. Furthermore, individuals from more deprived backgrounds (based on Indices of Multiple Deprivation (IMD) quintiles, which represent levels of socioeconomic deprivation across the UK) are more likely to experience hearing loss due to multiple factors related to health inequity. These include barriers to accessing health services and education; lifestyle factors, such as working in manual jobs where noise exposure is high; and experiencing poor cardiovascular health. Individuals with lower socioeconomic status are also likely to recover less well from the acute effects of chemotherapy due to reduced overall health and physiological resilience. Therefore, cancer patients living in Quintile 1 (Q1; the most socioeconomically deprived 20% of areas in the UK according to the IMD) may be particularly vulnerable to experiencing chemotherapy-induced hearing loss and therefore a reduced quality of life, after receiving platinum-based chemotherapy. No research has explored whether cancer patients from more deprived quintiles may be disproportionately affected by chemotherapy-induced hearing loss. Furthering understanding of the association between hearing health and socioeconomic deprivation will help to guide future hearing screening and intervention following platinum-based chemotherapy.

Individuals with hearing loss may be at greater risk of experiencing cognitive decline and dementia. Previous research indicates that long-term hearing loss is associated with structural changes in auditory brain areas, including brain atrophy. Such changes may reduce the quality of neural input to other regions involved in auditory processing and language comprehension, such as the temporal lobe. Consequently, individuals with hearing loss may not only struggle to perceive sounds clearly but may also experience difficulties understanding speech and engaging in social situations.

Additionally, individuals with hearing loss may rely more on cognitive resources to understand speech in noisy environments. If capacity-limited cognitive resources are redirected to support listening, there may be reduced cognitive resources available for other daily tasks. This is important in the context of cancer, as chemotherapy is already known to cause cognitive dysfunction, so-called 'chemo brain', which is also a risk factor for cognitive decline. This means that cancer patients receiving platinum-based chemotherapy drugs relative to non-platinum chemotherapy drugs have a potentially greater risk of cognitive decline: 1) from the risk of neural dysfunction associated with chemo brain, and 2) from the risk of ototoxicity associated with hearing loss. Further, hearing loss is associated with social withdrawal due to difficulties listening in noisy environments, which has been linked with increased feelings of loneliness and reduced mental well-being.

This research is particularly relevant to the North West of England, where approximately 32% of the population lives in the most deprived areas in England. This is reflected in cancer diagnosis rates, with the North West population being 25% more likely to be diagnosed with cancer than those in the rest of England. Health inequalities in this region may also contribute to a higher prevalence of hearing loss compared to those from the South of England. Among 61-70-year-olds, 21.8% in the North West experience hearing loss, compared to 14.6% in the South East. For those aged 71-80, the prevalence is even greater, with 43% in the North West affected compared to 35.7% in the South East. Furthermore, the proportion of deaths due to dementia and Alzheimer's disease in the North West was 12.6% in 2019 (n = 9060), which was the fourth highest in England and Wales.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients receiving platinum-based chemotherapy drugs
  • Living and treated within North West England
  • Able to complete an online hearing and cognitive test
  • Fluent in English

排除标准

  • Following cancer types: brain tumour/metastasis, head + neck, skin cancers around the ear, and adenoid cystic carcinoma of the auditory cortex
  • World Health Organisation performance status score of 3 or more
  • Stage 4 cancer
  • History of childhood deafness
  • Current or recent ear infections
  • Cochlear implant user
  • Known neurological impairment (e.g., stroke, traumatic brain injury, dementia)
  • Patients who look capacity to consent or complete study tasks

研究组 & 干预措施

Chemotherapy patients

Patients set to be treated with platinum-based chemotherapy drugs in the North West of England.

结局指标

主要结局

Speech Reception Threshold in noise (Digit Triplet Test, dB Signal-to-Noise Ratio)

时间窗: Assessments are conducted at baseline (pre-chemotherapy), within seven days of chemotherapy treatment ending, and 6 months post-chemotherapy.

Speech reception threshold measured using the Digit Triplet Test, defined as the signal-to-noise ratio at which 50% of digit triplets are correctly identified. A lower (more negative) signal-to-noise ratio value indicates better speech-in-noise performance. The Digit Triplet Test presents sequences of spoken three digits embedded in background noise, with the noise level fixed and the speech level adaptively varied to estimate the signal-to-noise ratio required for 50% correct recognition.

次要结局

  • Forwards Digit Span Task: Short-term Memory(Assessments are conducted at baseline (pre-chemotherapy), within seven days of chemotherapy treatment ending, and 6 months post-chemotherapy.)
  • Backwards Digit Span - Working Memory(Assessments are conducted at baseline (pre-chemotherapy), within seven days of chemotherapy treatment ending, and 6 months post-chemotherapy.)
  • Flanker Task: Executive function and Attentional Control(Assessments are conducted at baseline (pre-chemotherapy), within seven days of chemotherapy treatment ending, and 6 months post-chemotherapy.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Helen Nuttall

Dr. Helen Nuttall, Senior Lecturer in Cognitive Neuroscience

Lancaster University

研究点 (2)

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