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Trial registered on ANZCTR


Registration number
ACTRN12621000585820
Ethics application status
Approved
Date submitted
16/04/2021
Date registered
18/05/2021
Date last updated
29/09/2022
Date data sharing statement initially provided
18/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the effectiveness of Hospital-Based Manufactured Medical Device Restorabite for treatment of Trismus in adults after head and neck cancer surgery
Scientific title
Efficacy of Hospital-Based Manufactured Medical Device Restorabite for treatment of Trismus in adults after head and neck cancer surgery
Secondary ID [1] 303969 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trismus 321584 0
Head and Neck Cancer 321585 0
Condition category
Condition code
Musculoskeletal 319324 319324 0 0
Other muscular and skeletal disorders
Cancer 319325 319325 0 0
Head and neck
Oral and Gastrointestinal 319326 319326 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The use of Restorabite will be offered to participants for the treatment of trismus after head and neck cancer surgery in place of other standard of care devices such as Ark-J (stacked wooden tongue depressor) or TheraBite.

Restorabite is a mass produced and non-custom made device, however, participants will be assigned to a specific insert by treating speech pathologist and surgeon depending on the severity of trismus and the recovery from the surgery. Participants will be asked to be involved with following interventions.
• Passive jaw range of motion exercises using Restorabite
• Active jaw range of motion exercises using Restorabite
• 10 x 1hr weekly sessions face to face at speech pathology clinic at hospital or over telehealth with speech pathology with minimum 3 years' experience. Gradual progression through the force hierarchy as clinically indicated.
• Home practice: daily for 20 minutes for duration of study (10 weeks).
• Measurement of Interincisal distance at baseline, at the end of 10 x weekly sessions, 6 months and 12 months follow up appointment

Passive and active jaw range of motion exercises is a continuous exercise performed with Restorabite. It involves inserting the pressed down Restorabite between the front teeth and letting the device stretch the jaw (passive motion exercise) then bite down on the mouth guards (active motion exercise). Then repeat the letting go of the bite (passive motion exercise) and biting down on the device (active motion exercise). During the 1 hour weekly session, speech pathologist will determine how many repetitions should be carried out and recommend the duration of each exercise (ie Hold the passive action for 1 minute then hold the active action for 1 minute. Repeat 10 times). Participants will be asked to carry out a personalised exercise regime as home practice every day.
During the 1 hour weekly session, speech pathologist will determine the passive and active motion exercise regime for coming week. Interincisal distance will be measured at the start of the session then participants will be asked to carry out the prescribed exercise regime. Interincisal distance will be measured at the end of the session to observe a change in interincisal distance.

To monitor adherence to the intervention speech pathologists will closely follow up participants. To increase the adherence to the intervention, speech pathologists will set up a 10 week appointment plan at the beginning of the trial and also offer tele-health appointments.

Intervention code [1] 320278 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327195 0
Change in interincisal distance (distance between central incisors. If no dentition, 10mm for each set of teeth will be subtracted) measurement by speech pathologist with a minimum 3 years of experience using the TheraBite Range-of-Motion (ROM) (disposable paper measuring scales, specifically designed to allow patients and providers to measure the opening, movement and function of the mouth and jaw).
Timepoint [1] 327195 0
At baseline, the end of Intervention (10 week sessions), 6 months follow up and 12 months follow up.
Secondary outcome [1] 394137 0
Change in patient quality of life measured by below questionnaire.

• Gothenburg Trismus Questionnaire: patient reported outcome measure that measures the impact of trismus on the patient’s daily life.
Timepoint [1] 394137 0
At baseline, the end of Intervention (10 week sessions), 6 months follow up and 12 months follow up.
Secondary outcome [2] 395518 0
Change in patient quality of life measured by below questionnaire.

• Eating Assessment Tool – 10: patient reported outcome measure that enquires as to the symptoms of swallowing problems for patients
Timepoint [2] 395518 0
At baseline, the end of Intervention (10 week sessions), 6 months follow up and 12 months follow up.
Secondary outcome [3] 395519 0
Change in patient quality of life measured by below questionnaire.

• Speech Handicap Index (SHI): patient reported outcome measure that enquires as to the impact of speech problems on a patient’s daily life
Timepoint [3] 395519 0
At baseline, the end of Intervention (10 week sessions), 6 months follow up and 12 months follow up.
Secondary outcome [4] 395520 0
Change in patient quality of life measured by below questionnaire.

• MD Anderson Dysphagia Inventory (MDADI): patient reported outcome measure that enquires as to the impact of swallowing problems on a patient’s daily life
Timepoint [4] 395520 0
At baseline, the end of Intervention (10 week sessions), 6 months follow up and 12 months follow up.
Secondary outcome [5] 395521 0
Change in patient quality of life measured by below questionnaire.

• McGill Questionnaire (short form): describes the sensory dimension of pain including an overall intensity measure.
Timepoint [5] 395521 0
At baseline, the end of Intervention (10 week sessions), 6 months follow up and 12 months follow up.

Eligibility
Key inclusion criteria
• 18 years and older
• Diagnosis of head and neck cancer (HNC)
• Undergone surgery for their HNC
• Patients with an interincisal distance (IID) of 35mm or less
• Willingness to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients where trismus therapy is contraindicated due to medical/surgical parameters, guided by their managing physician.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
10/08/2021
Date of last participant enrolment
Anticipated
23/12/2022
Actual
Date of last data collection
Anticipated
23/12/2023
Actual
Sample size
Target
150
Accrual to date
120
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20868 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 20869 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 35689 0
2050 - Camperdown
Recruitment postcode(s) [2] 35690 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 308350 0
Hospital
Name [1] 308350 0
Chris O'Brien Lifehouse
Country [1] 308350 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
119-143 Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 309168 0
Government body
Name [1] 309168 0
Illawarra Shoalhaven Local Health District
Address [1] 309168 0
Locked Bag 8808
South Coast Mail Centre NSW 2521
Country [1] 309168 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308321 0
St Vincent’s Hospital HREC
Ethics committee address [1] 308321 0
Research Office

St Vincent’s Hospital Translational Research Centre

97-105 Boundary Street
Darlinghurst NSW 2010
Ethics committee country [1] 308321 0
Australia
Date submitted for ethics approval [1] 308321 0
16/04/2021
Approval date [1] 308321 0
09/06/2021
Ethics approval number [1] 308321 0
2021/ETH00758

Summary
Brief summary
This study aims to assess the efficacy of Restorabite, a trismus treatment device, as an early intervention for trismus and its impact on quality of life for patients with head and neck cancer.

Who is it for?
You may be eligible for this study if you are aged 18 or older, you have a diagnosis of head and neck cancer, and you are experiencing trouble opening your jaw wider than 35mm.

Study details
Participants will attend 10 x 1 hour weekly sessions with a speech pathologist, where they will be taken through passive and active jaw range of motion exercises. They will also be instructed to complete 20 minutes of home practice daily over the 10 week study period. Data on changes in jaw opening distance and quality of life will be collected over a 12 month period.

It is hoped that this study will demonstrate that the Restorabite device is effective in treating trismus in patients with head and neck cancer, which could lead to an improvement in quality of life for these patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110302 0
Prof Jonathan Clark
Address 110302 0
Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown NSW 2050
Country 110302 0
Australia
Phone 110302 0
+61 2 8514 0268
Fax 110302 0
Email 110302 0
[email protected]
Contact person for public queries
Name 110303 0
Masako Dunn
Address 110303 0
Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown NSW 2050
Country 110303 0
Australia
Phone 110303 0
+61 2 8514 0411
Fax 110303 0
Email 110303 0
[email protected]
Contact person for scientific queries
Name 110304 0
Jonathan Clark
Address 110304 0
Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown NSW 2050
Country 110304 0
Australia
Phone 110304 0
+61 2 8514 0268
Fax 110304 0
Email 110304 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11380Study protocol    381811-(Uploaded-16-04-2021-09-26-46)-Study-related document.docx
11381Informed consent form    381811-(Uploaded-16-04-2021-09-27-03)-Study-related document.doc


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11380Study protocol    381811-(Uploaded-21-11-2023-15-40-29)-Study-related document.docx
11381Informed consent form    381811-(Uploaded-21-11-2023-15-40-09)-Study-related document.doc

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.