Hearing Loss, SensorineuralNCT04270916
Prevalence and Impact on QoL From Ototoxicity in Cancer Survivors
An observational study of Hearing Loss, Sensorineural and Tinnitus, Subjective, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural, Tinnitus, Subjective, Cancer
- What is being tested?
- High frequency pure tone audiometry
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Feb 2020to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Previous radiotherapy to the head and neck area
- Pre-existing hearing deficits
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS trust
Nottingham, Nottinghamshire, NG5 1PB
About this study
Official title: 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.
Read the 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.
- Being tested
- High frequency pure tone audiometry
- Medical subject headings
- Hearing Loss, Sensorineural, Tinnitus, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency pure tone audiometryDiagnostic test
Hearing test carried out routinely, non invasive
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire
Short form 36 item questionnaire to assess quality of life (0-100 scale, higher score means better outcome)
Measured: Afer 6 months
Secondary outcomes (3)
Hearing loss
High frequency audiogram (PTA)
Measured: 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)
Measured: After 6 months
Tinnitus Handicap Inventory
Self reported tinnitus using the THI questionnaire (0-100 with higher scoring being more handicap)
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start3 Feb 2020
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, International Stem Cell Forum
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270916
- Sponsor's protocol ID
- 19039
- Status last verified
- Mar 2020
- First submitted
- 11 Feb 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal data will not be shared, however the overall statistical results grouping the cohort will be.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Prevalence, Severity and the Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04270916
- Acronym / sponsor ID
- 19039
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: due to COVID-19
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, International Stem Cell Forum
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Ability to give informed consent
Key exclusion criteria (2 listed)
- Previous radiotherapy to the head and neck area
- Pre-existing hearing deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High frequency pure tone audiometryHearing test carried out routinely, non invasive | Diagnostic test | – |
Primary outcome
Quality of life questionnaire
Time frame: Afer 6 months
Short form 36 item questionnaire to assess quality of life (0-100 scale, higher score means better outcome)
3 secondary outcomes
Hearing loss
Time frame: After 6 months
Hearing Handicap Inventory for adults/elderly
Time frame: After 6 months
Tinnitus Handicap Inventory
Time frame: After 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No. Personal data will not be shared, however the overall statistical results grouping the cohort will be.
Related trials for Hearing Loss, Sensorineural
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Otoferlin Gene-mediated Hearing Loss
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral Sensorineural
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Sensorineural and Tinnitus, Subjective, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life questionnaire (time frame: Afer 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.