1. Research into Practice Audiology Chemotherapy Ototoxicity Project

2. Why/Idea? Audiology provides both diagnostic and rehabilitation services for patients with hearing problems, balance disorders and tinnitus During routine clinics we found that we were seeing a number of patients referred via their GPs with hearing loss and tinnitus following chemo-radiation therapy (CRT) for head and neck cancer

3. Why/Idea? In many instances the patients had reached a stage were the hearing loss, balance problem or tinnitus was severely debilitating Hearing loss caused isolation from family and friends Tinnitus was causing anxiety and depression Many patients had the added distress of poor speech following surgery which added to their distress and isolation

4. Service evaluation We decided that we wished all patients to be offered a hearing, tinnitus and balance assessment at clinic following treatment with CRT in order to identify problems and assist with rehabilitation and coping strategies from an early stage

5. Practice development As part of the Head & Neck Practice Development Unit we looked into performing some collaborative work in order to improve the quality of life for this patient group With the help of the PDU, Consultants and specialist nurses we hope to offer all ENT Oncology patients a hearing assessment following treatment with chemoradiation

6. Service Evaluation Initial trial is for one ENT consultant to refer all patients who are being treated with chemoradiation for a hearing assessment, before and after treatment. Currently we do not know how many patients treated annually with chemoradiation Following on from the service evaluation we are in the process of seeking ethical approval for a research project

7. Research 50% of patients treated with CRT develop hearing loss – we wanted to know the figure amongst our local population Not a lot of research has been completed regarding the effects of treatment on tinnitus development and its impact As we have a well established and successful tinnitus service we wanted to develop advice and treatments at an early stage to improve the patients QoL

8. Decision to treat with chemo/radiation made at clinic within multidisciplinary team. Inclusion / exclusion criteria – Patients over the age of 16 treated for Head and Neck cancer with review appointments at UHA who have not received previous chemotherapy Consultation with consultant for treatment plan

9. New patient who has no previous history of head and neck cancer is approached as part of the Head & Neck 5000 Cohort study and given written information regarding the chemotherapy and its effects on the hearing and balance system Patients with previous Head & Neck cancer and not eligible for Head & Neck 5000 are approached by the Clinical Nurse specialist with verbal and written information about the chemotherapy study.

10. Patients asked if they are happy to receive a follow up phone call from a member of the Audiology department within the next 3-7 days. Within 7 days Tony Kay or Gaynor Chittick will contact the patient via telephone to confirm whether they wish to be part of this study and have an Audiological assessment. This will include questions regarding eligibility and be an opportunity for the patient to ask any questions regarding the study.

11. An appointment will be made at a mutually convenient time for the patient to attend the Audiology assessment. Patients will verbally agree to be part of this study at this time. Payment for transport and hospital parking will be met.

12. Patient completes chemoradiotherapy. At approximately 6-12 weeks after completion of their treatment they attend their routine Head & Neck Oncology review appointment and will be retested in the Audiology clinic. Any patients who previously declined to take part in the study will be asked if they have noticed any change in their hearing/balance or tinnitus and will be offered an Audiological assessment. Those patients who are found to have any change or deficits in their hearing/tinnitus or balance will be offered treatment as per standard treatment protocols.

13. Ethical issues : 1. If a patient has deafness or tinnitus at their baseline assessment should we advise that this may get worse following treatment with the possibility that they decide against chemotherapy. 2. Unilateral hearing loss – at what stage should we screen for AN. In view of the fact that AN are usually very slow growing. 3. Patient has significant tinnitus at baseline assessment. This could increase in loudness and intensity following chemotherapy and therefore patient would need to consider survival of cancer with possible long term tinnitus.

14. All patients are to be offered a hearing test pre and post treatment whilst in the clinic at the stage of referral for chemo/radiotherapy and then again at their 6/52 review. All patients will be offered the test whilst they are attending the clinic appointment to avoid unnecessary journeys to hospital and their time in clinic should hopefully not be extended significantly. An information leaflet will be given to each patient explaining the possible change in hearing following treatment. Referrals for Audiology assessment will be completed by the specialist nurses, the head and neck surgeons and oncologists. As with all hearing tests and Audiological examinations other underlying pathologies may be discovered which may require intervention and further investigation.

15. A10. What is the principal research question/objective? Please put this in language comprehensible to a lay person. To identify the incidence of hearing loss and tinnitus post chemo/radiotherapy treatment in patients with head and neck cancer who are treated at Aintree NHS Trust A11. What are the secondary research questions/objectives if applicable? Please put this in language comprehensible to a lay person The secondary research objective is to identify information that may be used to assist future decision-making by patients and clinicians in new cases. We hope to role out the findings of this study in order to offer appropriate counselling and treatment to all patients attending for chemo/radiotherapy so that early treatments and rehabilitation can be introduced..

16. A12. What is the scientific justification for the research? Please put this in language comprehensible to a lay person. Chemo and radiotherapy are known to be ototoxic and cause damage to the inner ear. We wish to identify this hearing loss and/or tinnitus at an early stage in order to offer amplification devices or rehabilitation in the form of tinnitus management.