Prevalence and Impact on QoL From Ototoxicity in Cancer Survivors

Suspended

• Conditions: Hearing Loss, Sensorineural; Tinnitus, Subjective; Cancer; Chemotherapeutic Toxicity

• Registration Number: NCT04270916
• Lead Sponsor: University of Nottingham

Brief Summary

This study will involve collaborating with oncologists in the post-chemotherapy follow-up appointments. The participants who wish to consent to this study will then answer 3 short questionnaires (THI, HHIA and SF-36) about hearing loss, tinnitus and quality of life. The audiologist or the researcher, under the supervision of an audiologist, will then perform a simple, non-invasive hearing test on the participant. Should the participant have a hearing loss, they will be advise to seek help from their General Practitioner.

Detailed Description

There has been a substantial increase in cancer survival rates in the the past decades, however many cancer survivors are now impacted by the multitude of toxicities associated with treatment. It is only when temporary toxicities subside that the long-term toxicities progress and become important. Chemotherapy, although highly effective, is known to cause ototoxicity, presenting as hearing loss and tinnitus. Hearing loss and tinnitus are associated with a higher risk of depression, dementia, social isolation and anxiety. There is little information and support offered to patients who suffer from ototoxicity, which can potentially lead to many being undiagnosed and untreated. Ototoxicity can be permanent and progressive, therefore it is essential that a deeper understanding and increased awareness of how hearing loss and tinnitus affects the quality of life (QoL) of cancer survivors can improve long-term symptoms Management and support offered.

This project aims to identify the prevalence and severity of long-term ototoxicity in cancer survivors following platinum-based treatment. Prevalence of ototoxicity can be unreliable and varies in the medical literature, with studies reporting rates between 24% and 79%. Information on prevalence will be achieved by recruiting patients from oncology clinics and performing a high frequency audiogram. The results from the audiogram will be compared to an normative dataset in addition to detecting self-reported hearing loss from the Hearing Handicap Inventory for Adults (HHIA) and the Hearing Handicap Inventory for Elderly (HHIE) questionnaires. Furthermore, the severity and prevalence of tinnitus will also be detected by using the Tinnitus Handicap Inventory (THI) questionnaire. A validated questionnaire assessing QoL (SF-36) after cancer will also be completed by the patients. The questionnaires will be statistically analysed and compared against a dataset from the general population in the hope to identify the concerns surrounding long-term ototoxicity in cancer survivors.

Study Timeline

• Study Start: 2020-02-03
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Ability to give informed consent

  • Age 18+ at time of cancer diagnosis
  • At least 1 cycle of any type of platinum-based chemotherapy
  • 0-5 years following first cycle of platinum-based chemotherapy
  • Comprehensive understanding of the English language

Exclusion Criteria

• Previous radiotherapy to the head and neck area
• Pre-existing hearing deficits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life questionnaire	Afer 6 months	Short form 36 item questionnaire to assess quality of life (0-100 scale, higher score means better outcome)

Secondary Outcome Measures

Name	Time	Method
Hearing Handicap Inventory for adults/elderly	After 6 months	Self reported hearing loss using the HHIA/HHIE questionnaire (0-100, higher score means more handicap)
Tinnitus Handicap Inventory	After 6 months	Self reported tinnitus using the THI questionnaire (0-100 with higher scoring being more handicap)
Hearing loss	After 6 months	High frequency audiogram (PTA)

Trial Locations

Locations (1)

Nottingham University Hospitals NHS trust; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom