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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281953
• Other study ID #: 18074
• Status: Completed
• Start date: September 5, 2019
• Est. completion date: February 28, 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Hearing Loss
• Hearing Loss, Sensorineural
• Late Effect
• Quality of Life
• Tinnitus
• Tinnitus, Subjective

Intervention

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)
• Hearing handicap inventory for adults/elderly (HHIA/HHIE)
Questionnaire on Hearing loss (Hearing handicap inventory for adults/elderly- HHIA/HHIE)
• Tinnitus handicap inventory (THI)
Questionnaire on Tinnitus (Tinnitus Handicap Inventory)

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	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	Prevalence of hearing loss	High frequency audiogram	Between 0-5 years
Secondary	Quality of life Questionnaire SF-36 (short-form 36 item)	Questionnaire on quality of life, scale between 0-100 with 0 being bad quality of life and 100 being good	Between 0-5 years
Secondary	Hearing Questionnaire HHIA/HHIE (hearing handicap inventory for adults/elderly)	Questionnaire on hearing loss scale from 0-100, 0 being no handicap and 100 being a big handicap	Between 0-5 years
Secondary	Tinnitus Questionnaire THI (tinnitus handicap inventory)	Questionnaire on Tinnitus from 0-100, 0 being no handicap and 100 being a bit handicap	Between 0-5 years