Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001324606
Ethics application status
Approved
Date submitted
28/11/2023
Date registered
18/12/2023
Date last updated
18/12/2023
Date data sharing statement initially provided
18/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Trismus exercise adherence during radiotherapy
Scientific title
A randomised control trial evaluating the effect of different trismus exercise regimens on adherence during radiation therapy for head and neck cancer
Secondary ID [1] 311021 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow up study to ACTRN12622001270707

Health condition
Health condition(s) or problem(s) studied:
trismus 332138 0
radiation therapy 332139 0
Condition category
Condition code
Cancer 328860 328860 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Restorabite is a trismus treatment device patent filed PCT/AU2022/050474

Participants will be randomised into three groups to assess the effectiveness of the adherence protocol in different exercise regimens - control, intervention 1 and intervention 2:

Intervention 1: Restorabite exercises regimen involving the lowest intensity stretch (the patient will be asked to use the lowest intensity which still achieves a stretch) for a long duration once per day for up to 12.5 minutes per day. This will be achieved by asking the participant to place the restorabite between upper and lower dentition or gums. The force will be selected based on the minimum intensity that the participant can perceive a stretch. They will keep the restorabite in their mouths for a maximum of 12.5 minutes per day.

Intervention 2: Restorabite exercises regimen involving the highest intensity stretch that they can manage for a short duration. This will be achieved by asking the participant to place the restorabite between upper and lower dentition or gums. The force will be selected based on the maximum intensity that the participant can tolerate without causing pain. They will keep the device in their mouth for the same amount of time as the standard care group

All: All participants in intervention groups 1 and 2 receive standard of care + interventions. Semi structured interview will be held to determine facilitators and barriers to preventative trismus exercises. The interviews will be conducted by investigators , independent of the treating clinicians. They will be offered in person, phone or online via Zoom or Microsoft Teams. If the participant elects to do this in person it can be arranged to coincide with a routine post-treatment review at the conclusion of their treatment. The computerised speech lab will be used to record the interviews.

Standard care refers to outcome measures already taken as part of routine practice, ‘study specific’ refers to those taken specifically for the purpose of this trial. All measures will be collated before starting radiotherapy, weekly during radiotherapy including last week of radiotherapy, 2 weeks, 3-, 6-, and 12- months post-radiotherapy, with exception of adherence reminders which will be sent daily for the 6-week duration of the radiotherapy therapy.

Following is the standard care:
Patients undergoing therapy are screened from the head and neck multidisciplinary team meeting and the weekly radiation therapy spreadsheet which is collated and distributed by the radiation oncology registrar.

Patients are contacted by phone to organise an initial assessment and education session prior to commencing radiotherapy with Speech Pathology and Nursing.

Initial speech pathology consult to assess swallow, mouth opening and trismus. This involves a measure of maximal mouth opening and mucositis scoring, and prescription of exercises including mouth opening and detection of minimum detectable force (measured in newtons)

Weekly appointments during radiotherapy (6 weeks) with the speech pathologist providing rehabilitation and support for speech, voice, swallowing and trismus. This includes general discussion about adherence to exercises and encouragement to complete them. Mucositis and MMO scoring

Follow up visits at 2 weeks, 4 weeks, 3-, 6- and 12-months post-radiation with the speech pathologist providing rehabilitation and support for speech, voice, swallowing and trismus. This includes general discussion about adherence to exercises and encouragement to complete them.

Following are the study specific steps when compared to standard care (above):
Study investigators will contact the patient’s surgeon and/or radiation oncologist to seek clearance to commence Restorabite trismus exercises during radiotherapy.

Potential participants will be informed of the study and invited to participate by one of the study investigators. They will have a minimum of 24 hours to consider their response. Their decision will have no effect on their clinical care. They will be assured that participation is entirely voluntary.

In addition to usual initial speech pathology consult, potential participants will be given a patient information sheet and consent form, and have the study explained to them by senior study investigator. This will include a discussion of all risks, benefits and alternatives to being involved. If they are willing to participate, they will sign a consent form. They will be given a signed copy of the patient information and consent form. With this will also be a withdrawal form should they chose to discontinue with the study at any time. Those who do not wish to participate will carry on with standard care treatment.

In addition to the routine weekly appointments during radiotherapy they will receive daily texts via Lifehouse installation of REDCap to remind about trismus exercises.

Weekly reviews will also include 12 item GTQ and adverse event reporting

Follow up visits will also include the 12-item GTQ and adverse event reporting

Participants will be invited to complete an interview with a study investigator as to the facilitators and barriers to adhering to the trismus program. Participants in the intervention groups will use the intervention for 12 months post radiotherapy with the secondary objective of this trial to check adherence to intervention.
Intervention code [1] 327471 0
Treatment: Devices
Comparator / control treatment
Standard care with stacked tongue depressors will be carried out, using a standard trismus exercise regimen - 30 s x 5 repetitions x 5 sets per day for a total of 12.5 minutes per day

Patients will be instructed to place a maximum number of wooden spatulas in between their front teeth for 30 seconds at a time, repeat this 5 times in a setting and do the same 5 times a day.

Outcome measures of adherence, maximal mouth opening (in millimeters), Gothenburg trismus questionnaire, CTCAE mucositis score and minimum detectable force will be recorded at standard appointment times of baseline, weekly during radiotherapy, 2 weeks post radiotherapy, 3-,6- and 12- months post radiotherapy.
Control group
Active

Outcomes
Primary outcome [1] 336661 0
Determine whether the stretching regimen impacts adherence during radiotherapy and at 3, 6 and 12 months post radiotherapy
Timepoint [1] 336661 0
Baseline at screening, enrolment visit, vist 1-6 during radiotherapy, 2 and 4 weeks, then 3, 6 and 12 months post radiotherapy
Secondary outcome [1] 429212 0
Maximal mouth opening MMO
Timepoint [1] 429212 0
Baseline at the time of enrolment, weekly during radiotherapy, 2 weeks post radiotherapy, 3-, 6- and 12- months post radiotherapy
Secondary outcome [2] 429702 0
Quality of life
Timepoint [2] 429702 0
Baseline at the time of enrolment, weekly during radiotherapy, 2 weeks post radiotherapy, 3-, 6- and 12- months post radiotherapy
Secondary outcome [3] 429703 0
Mucositis score
Timepoint [3] 429703 0
Baseline at the time of enrolment, weekly during radiotherapy, 2 weeks post radiotherapy, 3-, 6- and 12- months post radiotherapy
Secondary outcome [4] 429707 0
Minimum detectable force measured in newtons
Timepoint [4] 429707 0
Baseline at the time of enrolment, weekly during radiotherapy, 2 weeks post radiotherapy, 3-, 6- and 12- months post radiotherapy

Eligibility
Key inclusion criteria
1. Diagnosis of oral, oropharyngeal (base of tongue or tonsil) or nasopharyngeal cancer
2. Treatment involves radiotherapy in the definitive or adjuvant setting.
3. Willingness to provide informed consent and willingness to participate and comply with the study requirements
4. Able to complete questionnaires (with an interpreter/support person if necessary)
5. Adults, 18 years and over
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any participant who has non-union of the maxilla or mandible prior to commencing radiation (for example, if they had a jaw reconstruction which had not healed appropriately prior to radiation) or active osteoradionecrosis (ORN) (based on CT/X-RAY imaging after completing radiation). These conditions will be monitored by their treating surgeon at routine pre- and post-radiation review visits. Monitoring for non-union of the jaw after jaw surgery, and for signs of osteoradionecrosis after finishing radiation are routine practice/standard care. Signs include exposed bone, unmanaged pain or swelling, the managing radiation oncologist or surgeon would then recommend imaging within 1 week to investigate for non-union or ORN. If a patient is under investigation for non-union or ORN, they will be excluded from the trial.
2. Participants who have a pre-existing condition that is contraindicative of resistance-based jaw stretching exercises, for example arthritis of the temporomandibular joint, unstable dentition or any other joint degradation condition effecting the temporomandibular joint.


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)
REDCap randomisation module with randomisation table generated by SAS software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised until 31 patients are included in each group.
Participants will be randomised 1 to 1 to one of three arms: the control (standard care), intervention/ arm 1 of Restorabite exercise regimen using low intensity stretches for long duration and intervention/ arm 2 of Restorabite exercise regiment using high intensity stretch for short duration. This will be done using a computerised sequence generation via REDCap
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2024
Actual
Date of last participant enrolment
Anticipated
11/12/2024
Actual
Date of last data collection
Anticipated
11/11/2025
Actual
Sample size
Target
93
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315283 0
Hospital
Name [1] 315283 0
Chris O'Brien Lifehouse
Country [1] 315283 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
119 Missenden Road, Camperdown 2050 NSW
Country
Australia
Secondary sponsor category [1] 317324 0
None
Name [1] 317324 0
Address [1] 317324 0
Country [1] 317324 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314205 0
Sydney Local Health District Ethics Review Committe - Royal Prince Alfred Hospital Zone
Ethics committee address [1] 314205 0
Research ethics and governance office, Royal Prince Alfred Hospital, Camperdown NSW 2050
Ethics committee country [1] 314205 0
Australia
Date submitted for ethics approval [1] 314205 0
15/03/2023
Approval date [1] 314205 0
29/03/2023
Ethics approval number [1] 314205 0
2022/ETH02650

Summary
Brief summary
This study aims to explore how whether Restorabite, a device used to assist with stretching of the jaw, can help improve jaw function during radiotherapy for head and neck cancer and whether this has any impact on adherence to head and neck cancer treatment.

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 will be treated using radiotherapy.

Study details
Participants will be, by chance, provided one of three different treatments [in addition to standard care]:
- Group 1: a jaw stretching program using standard stacked tongue depressors
- Group 2: a low intensity stretching program using the Restorabite device
- Group 3: a high intensity stretching program using the Restorabite device
Participants will be asked to complete these jaw stretching exercise daily prior to starting radioatherapy upto 12 months after completing radioatherapy..

Information on jaw function and quality of life will be collected a total of 12 times at different timepoints via phone interviews and in person appointments for 12 months post radiotherapy.

It is hoped that this study will be able to show whether Restorabite can be used to improve jaw function and quality of life during radiotherapy treatment for those with head and neck cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130778 0
Dr Raymond Wu
Address 130778 0
119 Missenden Road, Camperdown NSW 2050 - Chris O'Brien Lifehouse
Country 130778 0
Australia
Phone 130778 0
+61 285140264
Fax 130778 0
Email 130778 0
raymond.wu@lh.org.au
Contact person for public queries
Name 130779 0
Dr Masako Dunn
Address 130779 0
119 Missenden Road, Camperdown NSW 2050 - Chris O'Brien Lifehouse
Country 130779 0
Australia
Phone 130779 0
+61 285140411
Fax 130779 0
Email 130779 0
masako.dunn@lh.org.au
Contact person for scientific queries
Name 130780 0
Prof Jonathan Clark
Address 130780 0
119 Missenden Road, Camperdown NSW 2050 - Chris O'Brien Lifehouse
Country 130780 0
Australia
Phone 130780 0
+61 285140268
Fax 130780 0
Email 130780 0
jonathan.clark@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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21069Study protocol    386930-(Uploaded-28-11-2023-08-49-33)-Study-related document.docx
21070Ethical approval    386930-(Uploaded-28-11-2023-08-51-02)-Study-related document.pdf



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.