Clinical trial NCT04270916: Prevalence and Impact on QoL From Ototoxicity in Cancer Survivors
Official title: Identifying the Prevalence, Severity and the Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Hearing Loss, Sensorineural
Tinnitus, Subjective
Cancer
Chemotherapeutic Toxicity
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: International Stem Cell Forum
First posted: 2020-02-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We aim to identify the prevalence of hearing loss and tinnitus and the impact on quality of life in people who have been treated with platinum based chemotherapy anywhere from 0-5 years ago. They can have any type of cancer as long as they were adults at the time of diagnosis and were treated with cisplatin, carboplatin or oxaliplatin.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life questionnaire
timeFrame: Afer 6 months
Secondary outcomes:
measure: Hearing loss
timeFrame: After 6 months
measure: Hearing Handicap Inventory for adults/elderly
timeFrame: After 6 months
measure: Tinnitus Handicap Inventory
timeFrame: After 6 months
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS trust
state: Nottinghamshire
Study officials:
References: