Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors

March 24, 2020 updated by: University of Nottingham

Long-term Ototoxicity in Cancer Survivors Treated With Chemotherapy and the Impact on Quality of Life

This project aims to explore, in depth, the burden of hearing loss and tinnitus on cancer survivors. Using semi-structured interviews, audiograms and a variety of validated questionnaires, the specific impact ototoxicity has on quality of life will be investigated.

From this, we can identify the specific needs of patients experiencing hearing loss and tinnitus following chemotherapy and develop a tailored and personalised support system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The medical and technological advances in cancer research have caused a decline in cancer deaths in recent decades. For example, the 5-year survival rate now is above 80% for many adult cancers, including breast and testicular cancers. In breast cancer alone, the mortality rate has reduced 39% since 1989 and currently has a 5 year survival rate over 90%. Due to this increase in survival rates and the intensity of treatment, many face long-term physical and psychological challenges in survivorship. Cancer survivors may experience altered body image and changes in sexual health and energy levels in addition to distress, anxiety, the fear of recurrence and the chronic side effects of their treatment. The need to research the long-term effects of chemotherapy and the impact they have on quality of life is crucial.

There is a need to broaden research beyond the survival rates and address the need for support for those who are adapting to a life after cancer. Survivors are left with often permanent and possible life-debilitating effects from treatment. To date, there has been little research on the specific late effects of chemotherapy and the associated impact on quality of life.

Platinum-based chemotherapy, although highly effective, is known to cause ototoxicity, presenting often as permanent high frequency hearing loss and tinnitus. Hearing loss and tinnitus are associated with a higher risk of depression, social isolation and anxiety. The quality of social interactions for a person with hearing loss and tinnitus is diminished as taking part in conversations becomes challenging. This is particularly problematic as it means that the quality of life of these cancer survivors is reduced.

The impact hearing loss and tinnitus has on quality of life in cancer survivors remains unclear and under-studied. Because cancer therapies can potentially cause life-threatening side effects such as cardiotoxicity and nephrotoxicity, these become the priority. However, once these side acute effects subside, other long-term side effects remain and can permanently reduce quality of life. Cancer survivors may have already experienced a difficult journey from the diagnosis itself, the physical challenges of treatment and finally, remission. Re-adapting back to their previous life whilst in remission, but with added permanent side effects, both physically and psychologically, can be extremely difficult for some survivors.

Currently, there is little information and support offered to these patients who suffer from ototoxicity, potentially leading to many being undiagnosed and untreated. These patients can be affected by this toxicity for the rest of their lives, which can have a detrimental impact on their quality of life. It is essential that a deeper understanding and increased awareness of how hearing loss and tinnitus affects the quality of life of cancer survivors is sought to improve long-term symptoms management and support offered. This study aims to develop this and improve the support given to cancer survivors.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, Ng7 2RD
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

People who have received platinum-based chemotherapy 0-5 years ago.

Description

Inclusion Criteria:

  • Has had platinum-based chemotherapy between 0-5 years ago
  • Has had at least 1 cycle- Was an adult (over 18) at the time of cancer diagnosis

Exclusion Criteria:

  • Pre-existing hearing issues
  • Radiotherapy to the head and neck area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People with ototoxicity
People living with and beyond who experience ototoxicity as a result of chemotherapy
Diagnostic test: High frequency audiometry
Simple hearing test
Other: Short-Form 36-Item Questionnaire (SF-36)
Questionnaire on quality of life (Short Form 36 Item- SF-36)
Other: Hearing handicap inventory for adults/elderly (HHIA/HHIE)
Questionnaire on Hearing loss (Hearing handicap inventory for adults/elderly- HHIA/HHIE)
Other: Tinnitus handicap inventory (THI)
Questionnaire on Tinnitus (Tinnitus Handicap Inventory)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of hearing loss
Time Frame: Between 0-5 years
High frequency audiogram
Between 0-5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life Questionnaire SF-36 (short-form 36 item)
Time Frame: Between 0-5 years
Questionnaire on quality of life, scale between 0-100 with 0 being bad quality of life and 100 being good
Between 0-5 years
Hearing Questionnaire HHIA/HHIE (hearing handicap inventory for adults/elderly)
Time Frame: Between 0-5 years
Questionnaire on hearing loss scale from 0-100, 0 being no handicap and 100 being a big handicap
Between 0-5 years
Tinnitus Questionnaire THI (tinnitus handicap inventory)
Time Frame: Between 0-5 years
Questionnaire on Tinnitus from 0-100, 0 being no handicap and 100 being a bit handicap
Between 0-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

National Institute for Health Research, United Kingdom
International Stem Cell Forum

Investigators

  • Principal Investigator: David Baguley, PhD, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 5, 2019

Primary Completion (ACTUAL)

February 28, 2020

Study Completion (ACTUAL)

February 28, 2020

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (ACTUAL)

February 24, 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

Other Study ID Numbers

  • 18074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be anonymised and made confidential, statistical analysis will be performed before data is shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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