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Trial registered on ANZCTR


Registration number
ACTRN12615001300561p
Ethics application status
Submitted, not yet approved
Date submitted
10/11/2015
Date registered
30/11/2015
Date last updated
30/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of Combined Modality Therapy on Sensorineural Hearing Loss in Patients with Head and Neck Cancer
Scientific title
For patients with head and neck mucosal sqaumous cell carcinoma, can stratified audiology risk profiles reduce rates of sensorineural hearing loss and increase patient quality of life?
Secondary ID [1] 287841 0
SNHLinHNC
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 296724 0
Sensorineural Hearing Loss 296725 0
Condition category
Condition code
Cancer 296957 296957 0 0
Head and neck
Ear 296958 296958 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293223 0
Prevention
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296569 0
Percentage change in Bone conduction thresholds as measured in pure tone audiometry
Timepoint [1] 296569 0
baseline, 5 weeks, 3 months post treatment and 1 year post treatment
Primary outcome [2] 296571 0
Percentage change in speech audiometry measured using speech discrimination score and speech reception threshold.
Timepoint [2] 296571 0
baseline, week 5 of treatment, 3 months post and 1 year post treatment
Secondary outcome [1] 318769 0
percentage of patients with onset of tinnitus as measured using the Tinnitus Handicap Inventory
Timepoint [1] 318769 0
Week 5 of treatment, 3 months post and 1 year post treatment
Secondary outcome [2] 318770 0
Change in participant quality of life with onset of SNHL as measured by the Hearing Handicap Inventory for Adults
Timepoint [2] 318770 0
Week 5 of treatment, 3 months post and 1 year post treatment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are allocated to a hearing loss risk profile based on a number of patient, tumour and treatment variables.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is not used
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analysis will include basic descriptive statistics and multivariate analysis (sample clustering, principal component analysis and logistic regression) to determine the relative contributions of factors including: patient demographics, tumour characteristics, chemotherapy regimen, cumulative chemotherapy dose, radiotherapy modality and pre-treatment hearing capability.

Descriptive statistics will also be reported for the results of the questionnaire. A factor analysis will be performed to determine the relationship among the items in the individual questionnaires. Person's correlation coefficient will also be used to compare the results for the three subscales in the Hearing Handicap Inventory subscales to the total questionnaire score. For all statistical tests, statistical significance will be defined as a p < 0.05. Data will be analysed using STATA (version 12.1, Stat-Corp LP, College Station, TX) software.

It is estimated that a sample size of 100 patients will be required for logistic regression analysis. However, due to a high number of variables and patient subtypes, this will be confirmed and updated following a sub-analysis of the first 20 patients accrued. Further analysis will be conducted if results are unequivocal.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/01/2016
Actual
Date of last participant enrolment
Anticipated
2/03/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4599 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 4600 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 12203 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 12204 0
4120 - Greenslopes

Funding & Sponsors
Funding source category [1] 292358 0
Self funded/Unfunded
Name [1] 292358 0
Unfunded (provided under standard of care)
Country [1] 292358 0
Primary sponsor type
Individual
Name
Phoebe Shorter
Address
Radiation Oncology
Division of Cancer Services
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
Queensland
4102
Country
Australia
Secondary sponsor category [1] 291039 0
Individual
Name [1] 291039 0
Dr Fiona Harden
Address [1] 291039 0
Faculty of Science and Engineering
Queensland University of Technology
GPO Box 2434, Brisbane, QLD, 4001
Country [1] 291039 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 293830 0
Metro South HREC
Ethics committee address [1] 293830 0
PAH Centres for Health Research
Level 7 Translational Research Institute
37 Kent Street
Woolloongabba
QLD
4102
Ethics committee country [1] 293830 0
Australia
Date submitted for ethics approval [1] 293830 0
10/11/2015
Approval date [1] 293830 0
Ethics approval number [1] 293830 0
Ethics committee name [2] 293937 0
Greenslopes Private Hospital HREC
Ethics committee address [2] 293937 0
Greenslopes Private Hospital
Newdegate Street
Greenslopes
QLD
4120
Ethics committee country [2] 293937 0
Australia
Date submitted for ethics approval [2] 293937 0
07/12/2015
Approval date [2] 293937 0
Ethics approval number [2] 293937 0
Ethics committee name [3] 293938 0
Queensland University of Technology HREC
Ethics committee address [3] 293938 0
2 George Street
Brisbane
QLD
4000
Ethics committee country [3] 293938 0
Australia
Date submitted for ethics approval [3] 293938 0
21/12/2015
Approval date [3] 293938 0
Ethics approval number [3] 293938 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61406 0
Mrs Phoebe Shorter
Address 61406 0
Radiation Oncology
Division of Cancer Services
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD
4102
Country 61406 0
Australia
Phone 61406 0
+6128865522
Fax 61406 0
Email 61406 0
[email protected]
Contact person for public queries
Name 61407 0
Phoebe Shorter
Address 61407 0
Radiation Oncology
Division of Cancer Services
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD
4102
Country 61407 0
Australia
Phone 61407 0
+6128865522
Fax 61407 0
Email 61407 0
[email protected]
Contact person for scientific queries
Name 61408 0
Phoebe Shorter
Address 61408 0
Radiation Oncology
Division of Cancer Services
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD
4102
Country 61408 0
Australia
Phone 61408 0
+6128865522
Fax 61408 0
Email 61408 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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