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Trial registered on ANZCTR


Registration number
ACTRN12622001270707p
Ethics application status
Not yet submitted
Date submitted
19/09/2022
Date registered
26/09/2022
Date last updated
26/09/2022
Date data sharing statement initially provided
26/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising Adherence Pilot Program: Investigating the impact of a novel intervention on the incidence of trismus during radiotherapy for head and neck cancer patients
Scientific title
Optimising Adherence Pilot Program: Investigating the impact of a novel intervention on the incidence of trismus during radiotherapy for head and neck cancer patients
Secondary ID [1] 308001 0
none
Universal Trial Number (UTN)
Trial acronym
PreTrisHNCPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
trismus 327670 0
head and neck cancer 327671 0
Condition category
Condition code
Musculoskeletal 324753 324753 0 0
Other muscular and skeletal disorders
Cancer 324754 324754 0 0
Head and neck
Oral and Gastrointestinal 324755 324755 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
Restorabite, a new, class I medical device used for the treatment of trismus (restricted mouth opening) will be piloted in a preventative context for patients undergoing radiotherapy for head and neck cancer. This replaces traditional devices such as stacking tongue depressors and inserting between the teeth, or TheraBite. This trial will investigate how to best facilitate adherence to trismus exercises during radiotherapy.

This pilot program will randomise participants into the standard care or intervention group. The intervention group will have a pre-radiation education session about trismus which will cover how to measure their mouth opening and their exercise program during radiation. It is anticipated to last 30 minutes of face-to-face time. It will occur at time of radiation planning approximately 2-3 weeks prior to radiation commencing. This information and education session involving verbal/physical instructions given by the speech pathologist is intended to improve the patient's understanding of trismus and independence monitoring and managing the condition. They will get daily text reminders to complete their exercises during radiotherapy treatment. Adherence to exercises and maximal mouth opening will be measured in both groups. This will be monitored using REDCap software delivery system and by the clinical manager who will monitor the data being collected. The maximum duration participants will received text messages is 6 weeks. Any participant who would prefer not to receive text messages will be offered use of a paper based exercise diary.

The intervention groups will be taught how to carry out passive and active jaw range of motion exercises is a continuous exercise performed with Restorabite. It involves inserting the pressed down Restorabite between the teeth and letting the device stretch the jaw (passive motion exercise) then bite down on the mouth guards (active motion exercise). Their home practice will be a maximum of 15 minutes per day comprising of up to 60 second stretches, 10 repetitions, 5 sets per day. During the weekly reviews during radiotherapy the speech pathologist will measure the patient's mouth opening and review the exercises assigned to them, as well as manage any barriers encountered to exercise adherence.

At the end of radiotherapy, patients will continue to exercise with Restorabite and monitoring their mouth opening independently, with ongoing assistance from speech pathology as required on a case by case basis.
Intervention code [1] 324455 0
Treatment: Devices
Comparator / control treatment
Phase 1 control group: patients undergoing radiotherapy for head and neck cancer are routinely reviewed either weekly during their treatment by a speech pathologist experienced in trismus, swallowing and speech disorders. This will continue, per standard care at our institution.

Control group
Active

Outcomes
Primary outcome [1] 332574 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] 332574 0
baseline (pre-radiotherapy), weekly during radiotherapy, 2 weeks post radiotherapy, 3-, 6- and 12-months post radiotherapy
Primary outcome [2] 332575 0
Adherence to exercises (how many days of the week did the patient meet their exercise goal?)
this will be measured by the responses provided using text based REDCap survey and/or exercise journal audit
Timepoint [2] 332575 0
baseline (pre-radiotherapy), weekly during radiotherapy, 2 weeks post radiotherapy, 3-, 6- and 12-months post radiotherapy
Primary outcome [3] 332576 0
Gothenburg Trismus Questionnaire: patient reported outcome measure that measures the impact of trismus on the patient’s daily life.
Timepoint [3] 332576 0
baseline (pre-radiotherapy), weekly during radiotherapy, 2 weeks post radiotherapy, 3-, 6- and 12-months post radiotherapy
Secondary outcome [1] 413956 0
Common Terminology Criteria for Adverse Events: Mucositis
Timepoint [1] 413956 0
baseline (pre-radiotherapy), weekly during radiotherapy, 2 weeks post radiotherapy, 3-, 6- and 12-months post radiotherapy

Eligibility
Key inclusion criteria
• 18 years and older
• Diagnosis of head and neck cancer (HNC)
• Planned for radiotherapy to treat HNC
• 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
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Generalised estimating equations
Descriptive statistics
linear regression

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/11/2022
Actual
Date of last participant enrolment
Anticipated
27/11/2023
Actual
Date of last data collection
Anticipated
25/11/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23176 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 23177 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 38541 0
2050 - Camperdown
Recruitment postcode(s) [2] 38542 0
2050 - Missenden Road

Funding & Sponsors
Funding source category [1] 312265 0
Hospital
Name [1] 312265 0
Chris O'Brien Lifehouse
Country [1] 312265 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
119-143 Missenden Road, Camperdown, 2050 NSW
Country
Australia
Secondary sponsor category [1] 313806 0
Hospital
Name [1] 313806 0
Royal Prince Alfred Hospital
Address [1] 313806 0
Queen Elizabeth II building
57-59 Missenden Rd, Camperdown NSW 2050
Country [1] 313806 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311638 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 311638 0
Ethics committee country [1] 311638 0
Australia
Date submitted for ethics approval [1] 311638 0
03/10/2022
Approval date [1] 311638 0
Ethics approval number [1] 311638 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121810 0
Dr Emma Charters
Address 121810 0
Level 7, Allied Health Office
Chris O'Brien Lifehouse
119-143 Missenden Road,
Camperdown, NSW 2050
Country 121810 0
Australia
Phone 121810 0
+61 413660776
Fax 121810 0
Email 121810 0
emma.charters@lh.org.au
Contact person for public queries
Name 121811 0
Masako Dunn
Address 121811 0

Chris O'Brien Lifehouse
119-143 Missenden Road,
Camperdown, NSW 2050
Country 121811 0
Australia
Phone 121811 0
+61 2 85140268
Fax 121811 0
Email 121811 0
masako.dunn@lh.org.au
Contact person for scientific queries
Name 121812 0
Emma Charters
Address 121812 0
Level 7, Allied Health Office
Chris O'Brien Lifehouse
119-143 Missenden Road,
Camperdown, NSW 2050
Country 121812 0
Australia
Phone 121812 0
+61 413660776
Fax 121812 0
Email 121812 0
emma.charters@lh.org.au

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?

No Supporting Document Provided



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.