Chemotherapy-Induced Hearing Loss and Health Inequality
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLancaster University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Cancer patients who will be treated with platinum-based chemotherapy drugs within the North West of England. Participants will be recruited from NHS Hospital Trusts from across the North West of England.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
172 Participants
are grouped into 1 trial groupGroup A: Chemotherapy patients
Trial outcomes
Primary outcomes
1
Speech Reception Threshold in noise (Digit Triplet Test, dB Signal-to-Noise Ratio)
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.
Time frame
Assessments are conducted at baseline (pre-chemotherapy), within seven days of chemotherapy treatment ending, and 6 months post-chemotherapy.Secondary outcomes
1
Forwards Digit Span Task: Short-term Memory
Participants will complete the Forward Digit Span Test, a cognitive assessment used to evaluate short-term memory and attention. The test takes approximately five minutes to complete, during which participants will be shown a sequence of digits on a screen and required to recall them in the same order. The length of the digit sequence increases with each correct response. This test measures short-term memory, providing insight into an individual's ability to temporarily store and recall information in everyday settings.
Time frame
Assessments are conducted at baseline (pre-chemotherapy), within seven days of chemotherapy treatment ending, and 6 months post-chemotherapy.2
Backwards Digit Span - Working Memory
Participants will complete the Backwards Digit Span Test, a cognitive assessment designed to measure working memory. The test takes approximately five minutes to complete, during which participants will be shown a sequence of digits on a screen and must recall them in reverse order. The test becomes progressively more challenging as the digit sequences increase in length. This test evaluates an individual's working memory.
Time frame
Assessments are conducted at baseline (pre-chemotherapy), within seven days of chemotherapy treatment ending, and 6 months post-chemotherapy.3
Flanker Task: Executive function and Attentional Control
Cognitive performance assessed using a computerised Flanker Task administered via Pavlovia. Outcomes include response accuracy (% correct).
Time frame
Assessments are conducted at baseline (pre-chemotherapy), within seven days of chemotherapy treatment ending, and 6 months post-chemotherapy.4
Flanker Task: Executive function and Attentional Control
Cognitive performance assessed using a computerised Flanker Task administered via Pavlovia. Outcomes include mean reaction time (milliseconds) on correct trials.
Time frame
Assessments are conducted at baseline (pre-chemotherapy), within seven days of chemotherapy treatment ending, and 6 months post-chemotherapy.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lancaster University
Lead sponsor
East Lancashire Hospitals NHS Trust
Collaborator
Lancashire Teaching Hospitals NHS Foundation Trust
Collaborator
University Hospitals of Morecambe Bay NHS Trust
Collaborator
Source ClinicalTrials.gov