Prevalence and Impact on QoL From Ototoxicity in Cancer Survivors

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

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.

Study Overview

• Status: Suspended
• Conditions: Cancer; Hearing Loss, Sensorineural; Tinnitus, Subjective; Chemotherapeutic Toxicity
• Intervention / Treatment: Diagnostic test: High frequency pure tone audiometry

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 Type: Observational
• Enrollment (Anticipated): 46

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Nottingham University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing loss	High frequency audiogram (PTA)	After 6 months
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
Tinnitus Handicap Inventory	Self reported tinnitus using the THI questionnaire (0-100 with higher scoring being more handicap)	After 6 months

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: National Institute for Health Research, United Kingdom; International Stem Cell Forum

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 3, 2020
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Hearing Loss; Ototoxicity; Hearing Loss, Sensorineural; Tinnitus
• Other Study ID Numbers: 19039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Personal data will not be shared, however the overall statistical results grouping the cohort will be.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No