None listed
Conditions
Brief summary
The primary aim of this trial is to develop and evaluate a risk model to aid doctors to identify head and neck cancer patients who are most at risk of developing hearing loss as a result of treatment. Who is it for? You may be eligible to participate in this trial if you are aged 18 or older and have been diagnosed with a head or neck squamous cell carcinoma for which you have been scheduled to receive radiotherapy at the Princess Alexandra Hospital. Study details All participants in this study will first be allocated to one of the two study groups based on their risk of developing hearing loss during treatment. Those identified as minimal risk will receive standard radiotherapy care. Those identified as high risk will receive a new protocol of radiotherapy care following the guidelines developed by these researchers. This care includes tighter radiation dose tolerances for your ear structures and the use of a validated, audiology contouring atlas to ensure more accurate definition of your ear structures on your radiotherapy planning scan. These recommendations are expected to be followed unless it is not in the best interest of treatment of the cancer. All patients will have hearing test visits before treatment, at week 5 of treatment, at 3 months and at 1 year after finish of treatment. Outcomes will be assessed using results of these hearing tests and by questionnaires completed by participants. It is hoped that the findings of this study will provide more information on the radiotherapy dose required to induce hearing loss, any links to specific chemotherapy drugs which may increase risk of hearing loss and the efficacy of the risk profiling tool to identify patients at greatest risk of developing hearing loss.
Interventions
The primary aim of this study is to develop a stratified risk model for patients who are most at risk of developing sensorineural hearing loss (SNHL). Participants will be allocated to a risk profile prior to their radiotherapy planning. These risk profiles include minimal risk of hearing loss and increased risk of hearing loss, with participant allocation based on tobacco and alcohol consumption, chemotherapy agent and cumulative chemotherapy dose. Participants in both risk profiles will have their chemotherapy delivered according to standard department protocol. Participants in both risk profiles will have their radiotherapy simulation conducted according to department protocol. This involves a CT scan, used to define organs and disease, lasting approximately 20 minutes. Participants assigned to the minimal risk profile will have their radiotherapy planned according to standard protocol. Participants assigned to the increased risk profile will have their radiotherapy planned using stricter, standardised guidelines. These guidelines will create consistency in HNC radiotherapy planning and include the following: - the planning radiotherapist will be responsible for defining audiology structures using the validated, audiology contouring atlas, developed and validated in phase one. This will ensure standardisation in the accuracy of contours. All contours will be checked for accuracy by the prescribing Radiation Oncologist. - a standardised ear radiation dose tolerance will be prescribed by the Radiation Oncologist. Currently, due to a lack of evidence based literature, ear tolerances vary greatly between physicians as it’s subject to physician preference. These tolerances were derived using information gathered in phase one, in conjunction with literature and oncologist clinical experience. It is important to note, that achieving these tolerances will not take priority over tumour coverage. Further, if a tighter dose tolerance is favourable, this is acceptable. In addition, all participants will undergo audiology testing. Current practice sees patients referred for audiology assessment when they complain of hearing loss. For this study, patients will undergo audiology assessment at four pre-determined time intervals throughout their treatment (before treatment, week 5 of treatment, 6-12 weeks and 1 year after treatment). Each session will last for approximately 45 minutes in pure tone audiometry, otoacoustic emissions testing, reflexometry and tympannometry testing will be carried out using beeps, whistle and word repetition. Two questionnaires will also be provided for completion at each of the follow up examinations and will take approximately 15 minutes to complete.. The outcomes of these questionnaires will enable the comparison of subjective and objective hearing results.
Sponsors
Study design
Eligibility
Inclusion criteria
Histopathologically confirmed head and neck squamous cell carcinoma; all mucosal primary subsites accepted Tumour classified as stage II – IV, according to the TNM classification The patient must be a candidate for combined modality therapy, in either the definitive or postoperative setting The patient must be booked to received external beam radiotherapy at the Princess Alexandra Hospital Has provided written, informed consent for participation in the study
Exclusion criteria
Distant Metastases Palliative Radiotherapy Extension of disease into the auditory system Previous external beam radiotherapy to the head and neck region Incomplete radiotherapy or absence of baseline audiology testing Pre-existing otological condition (i.e Meniere’s disease) that may influence the outcome of audiological assessment The patient should not be in state or condition that is expected to influence the outcome of treatment, complicate the audiological assessment or follow-up, or reduce life expectancy (apart from the present disease) Sufficient proficiency in English, cognitive capacity and willingness to complete questionnaires Pregnant