Prevalence and Impact on QoL From Ototoxicity in Cancer Survivors

Cancer Clinical Trial

Official title:

Identifying the Prevalence, Severity and the Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors: a Cross-sectional Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04270916
• Other study ID #: 19039
• Status: Suspended
• Start date: February 3, 2020
• Est. completion date: September 2020

Study information

• Verified date: March 2020
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 46
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Chemotherapeutic Toxicity
• Hearing Loss
• Hearing Loss, Sensorineural
• Tinnitus
• Tinnitus, Subjective

Intervention

Diagnostic Test:
• High frequency pure tone audiometry
Hearing test carried out routinely, non invasive

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS trust	Nottingham	Nottinghamshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Nottingham	International Stem Cell Forum, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life questionnaire	Short form 36 item questionnaire to assess quality of life (0-100 scale, higher score means better outcome)	Afer 6 months
Secondary	Hearing loss	High frequency audiogram (PTA)	After 6 months
Secondary	Hearing Handicap Inventory for adults/elderly	Self reported hearing loss using the HHIA/HHIE questionnaire (0-100, higher score means more handicap)	After 6 months
Secondary	Tinnitus Handicap Inventory	Self reported tinnitus using the THI questionnaire (0-100 with higher scoring being more handicap)	After 6 months