NCT07553481

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
28mo left

Started May 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Sep 2028

First Submitted

Initial submission to the registry

April 13, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 2, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

April 13, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

CancerChemo brainChemotherapyHearing

Outcome Measures

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.

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

Secondary Outcomes (5)

  • 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.

  • 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.

  • 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.

Study Arms (1)

Chemotherapy patients

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lancaster University

Lancaster, Lancashire, LA1 4YW, United Kingdom

Location

Related Publications (17)

  • Slade K, Reilly JH, Jablonska K, Smith E, Hayes LD, Plack CJ, Nuttall HE. The impact of age-related hearing loss on structural neuroanatomy: A meta-analysis. Front Neurol. 2022 Aug 8;13:950997. doi: 10.3389/fneur.2022.950997. eCollection 2022.

    PMID: 36003293BACKGROUND
  • De Sousa KC, Swanepoel W, Moore DR, Myburgh HC, Smits C. Improving Sensitivity of the Digits-In-Noise Test Using Antiphasic Stimuli. Ear Hear. 2020 Mar/Apr;41(2):442-450. doi: 10.1097/AUD.0000000000000775.

    PMID: 31425362BACKGROUND
  • De Sousa KC, Smits C, Moore DR, Myburgh HC, Swanepoel W. Diotic and Antiphasic Digits-in-noise Testing as a Hearing Screening and Triage Tool to Classify Type of Hearing Loss. Ear Hear. 2022 May/Jun;43(3):1037-1048. doi: 10.1097/AUD.0000000000001160.

    PMID: 34799493BACKGROUND
  • Ahmad T, Ullah AZMD, Chelala C, Taylor SJC. Ethnic and Socio-Economic Variations in Comorbidity and Mortality in Cancer Survivors: A UK Population-Based Observational Study. Cancers (Basel). 2025 Mar 14;17(6):983. doi: 10.3390/cancers17060983.

    PMID: 40149316BACKGROUND
  • Exarchakou A, Kipourou DK, Belot A, Rachet B. Socio-economic inequalities in cancer survival: how do they translate into Number of Life-Years Lost? Br J Cancer. 2022 Jun;126(10):1490-1498. doi: 10.1038/s41416-022-01720-x. Epub 2022 Feb 11.

    PMID: 35149855BACKGROUND
  • Tsimpida D, Panagioti M, Kontopantelis E. Forty years on: a new national study of hearing in England and implications for global hearing health policy. Int J Audiol. 2023 Jan;62(1):62-70. doi: 10.1080/14992027.2021.2022791. Epub 2022 Jan 26.

    PMID: 35080184BACKGROUND
  • Stangler LTB, de Almeida Robatto AA, Galvao Freire PJ, de Castro Junior G. The challenge of chemotherapy-related cognitive impairment: assessing and managing cognitive decline after cancer treatment. Ecancermedicalscience. 2025 Aug 5;19:1958. doi: 10.3332/ecancer.2025.1958. eCollection 2025.

    PMID: 41333365BACKGROUND
  • Li M, Caeyenberghs K. Longitudinal assessment of chemotherapy-induced changes in brain and cognitive functioning: A systematic review. Neurosci Biobehav Rev. 2018 Sep;92:304-317. doi: 10.1016/j.neubiorev.2018.05.019. Epub 2018 May 20.

    PMID: 29791867BACKGROUND
  • McCoy SL, Tun PA, Cox LC, Colangelo M, Stewart RA, Wingfield A. Hearing loss and perceptual effort: downstream effects on older adults' memory for speech. Q J Exp Psychol A. 2005 Jan;58(1):22-33. doi: 10.1080/02724980443000151.

    PMID: 15881289BACKGROUND
  • Shukla A, Harper M, Pedersen E, Goman A, Suen JJ, Price C, Applebaum J, Hoyer M, Lin FR, Reed NS. Hearing Loss, Loneliness, and Social Isolation: A Systematic Review. Otolaryngol Head Neck Surg. 2020 May;162(5):622-633. doi: 10.1177/0194599820910377. Epub 2020 Mar 10.

    PMID: 32151193BACKGROUND
  • Cascella M, Di Napoli R, Carbone D, Cuomo GF, Bimonte S, Muzio MR. Chemotherapy-related cognitive impairment: mechanisms, clinical features and research perspectives. Recenti Prog Med. 2018 Nov;109(11):523-530. doi: 10.1701/3031.30289.

    PMID: 30565571BACKGROUND
  • Slade K, Plack CJ, Nuttall HE. The Effects of Age-Related Hearing Loss on the Brain and Cognitive Function. Trends Neurosci. 2020 Oct;43(10):810-821. doi: 10.1016/j.tins.2020.07.005. Epub 2020 Aug 19.

    PMID: 32826080BACKGROUND
  • Griffiths TD, Lad M, Kumar S, Holmes E, McMurray B, Maguire EA, Billig AJ, Sedley W. How Can Hearing Loss Cause Dementia? Neuron. 2020 Nov 11;108(3):401-412. doi: 10.1016/j.neuron.2020.08.003. Epub 2020 Aug 31.

    PMID: 32871106BACKGROUND
  • Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available.

    PMID: 32738937BACKGROUND
  • Tsimpida D, Kontopantelis E, Ashcroft D, Panagioti M. Socioeconomic and lifestyle factors associated with hearing loss in older adults: a cross-sectional study of the English Longitudinal Study of Ageing (ELSA). BMJ Open. 2019 Sep 17;9(9):e031030. doi: 10.1136/bmjopen-2019-031030.

    PMID: 31530617BACKGROUND
  • Chattaraj A, Syed MP, Low CA, Owonikoko TK. Cisplatin-Induced Ototoxicity: A Concise Review of the Burden, Prevention, and Interception Strategies. JCO Oncol Pract. 2023 May;19(5):278-283. doi: 10.1200/OP.22.00710. Epub 2023 Mar 15.

    PMID: 36921239BACKGROUND
  • Dillard LK, Lopez-Perez L, Martinez RX, Fullerton AM, Chadha S, McMahon CM. Global burden of ototoxic hearing loss associated with platinum-based cancer treatment: A systematic review and meta-analysis. Cancer Epidemiol. 2022 Aug;79:102203. doi: 10.1016/j.canep.2022.102203. Epub 2022 Jun 17.

    PMID: 35724557BACKGROUND

Related Links

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Helen Nuttall, Senior Lecturer in Cognitive Neuroscience

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 28, 2026

Study Start

May 2, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations