Oropharyngeal CancerPhase 2NCT01733797
Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients
A Phase 2 study testing Wooden spatula and Therabite in people with Oropharyngeal Cancer and Oral Cancer, run by Brynn Chappell at 5 sites in United Kingdom.
Trial summary
The trial will compare exercises using Therabite® versus wooden spatulas to prevent or relieve trismus in patients with stage 3 and 4 oral/oropharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Cancer, Oral Cancer
- What is being tested?
- Wooden spatula and Therabite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Dec 2012to Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed, written informed consent
- Aged 18 years and older
- Able to read and write English sufficiently to be able to complete questionnaires
- Stage 3/4 oral and oropharyngeal cancer patients undergoing:
- Primary chemoradiotherapy or Surgical free flap plus post operative radiotherapy or post operative chemoradiotherapy
- All patients will receive 60-70 Gy in 30-35 fractions over 6 to 7 weeks to the region of the pterygoid muscles.
- All patients will have at least some trismus as indicated by subjective tightening in the jaw.
Who cannot join
- <12mm mouth opening (cannot use Therabite)
- Anatomically unable to use Therabite for example patients who may only be partially dentate and to use the Therabite would place extreme stress on the existing teeth
- Cognitive impairment as judged by the clinicians
- International patients treated who will not have routine UK follow up.
- Previous surgery or RT to the head and neck prior to this diagnosis
- Any patient who has no subjective tightening of the jaw.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
Queen Victoria Hospital
East Grinstead, RH19 3DZ
Aintree University Hospitals NHS Foundation Trust
Liverpool, L9 7AL
The Christie NHS Foundation Trust
Manchester, M20 4BX
York Hospital
York, YO31 8HE
About this study
Official title: Randomised Pilot Study of Therabite® Versus Wooden Spatula in the Amelioration of Trismus in Head and Neck Cancer Patients. (Trismus Trial)
The trial will compare exercises using Therabite® versus wooden spatulas to prevent or relieve trismus in patients with stage 3 and 4 oral/oropharyngeal cancer.
Read the detailed description
Trismus is defined as a tightening of jaw opening. The negative impact of Trismus on the quality of life of head and neck cancer patients is well established. It affects eating, drinking, speaking and social function and is often as debilitating as any disfigurement resulting from treatment.
The use of jaw exercises using a Therabite appliance following treatment has been shown to reduce the level of Trismus in small studies. Many UK centres, however, use stacked wooden spatulas inserted between the incisors as a means of passive exercise. There is anecdotal evidence that suggests the use of exercises prior to treatment may help reduce the severity of the Trismus experienced by the patient.
This study will enrol 112 head and neck cancer patients allocated by chance to use either the Therabite or wooden spatula and patients will be asked to perform mouth exercises on a daily basis for 6 months.
There is a need to evaluate both the clinical effectiveness and cost-effectiveness of Therabite as opposed to wooden spatulas to determine whether they should be adopted as standard care in head and neck cancer patients.
In this pilot trial, the investigators will measure benefits of Therabite to patients, as compared to usual care with wooden spatulas. Mouth opening will be the key outcome for the study.
- Conditions
- Oropharyngeal Cancer, Oral Cancer
- Being tested
- Wooden spatula, Therabite
- Keywords
- Trismus, Therabite, Wooden spatula, Head and Neck cancer
- Medical subject headings
- Oropharyngeal Neoplasms, Mouth Neoplasms, Trismus, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wooden spatulaDevice
Lollipop sticks placed between incisors
TherabiteDevice
Hand held device placed in mouth that exercises the jaw
| Study group | Role | What they receive |
|---|---|---|
| Wooden spatula | Experimental | Not described Receives: Device: Wooden spatula |
| Therabite | Experimental | Not described Receives: Device: Therabite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Jaw measurement
Willis bite calliper will be used to measure the jaw opening at baseline, 3 and 6 months
Measured: Baseline, 3 months and 6 months at hopsital
Secondary outcomes (3)
Adherence to intervention
Adherence to device use will be captured by the patient on a progress log
Measured: up to 6 months
Quality of Life
Measured: Baseline, 3 and 6 months
Health economic analysis
Patients hospital and service use will be captured at Baseline, 3 and 6 months during interviews with the patient.
Units used will be days in hospital or number of appointments
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brynn Chappell
- Sponsor type
- University, hospital or other
- Collaborators
- The Christie NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Brynn Chappell, The Christie NHS Foundation Trust
- Investigators
- Prof Slevin, Study chair, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733797
- Sponsor's protocol ID
- 09DOG0843
- Other IDs
- ISRCTN79084153, PB-PG-0610-22317
- Status last verified
- Sep 2015
- First submitted
- 19 Nov 2012
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee R, Molassiotis A, Rogers SN, Edwards RT, Ryder D, Slevin N. Protocol for the trismus trial-therabite versus wooden spatula in the amelioration of trismus in patients with head and neck cancer: randomised pilot study. BMJ Open. 2018 Mar 30;8(3):e021938. doi: 10.1136/bmjopen-2018-021938.
PubMed 29602860Lee R, Yeo ST, Rogers SN, Caress AL, Molassiotis A, Ryder D, Sanghera P, Lunt C, Scott B, Keeley P, Edwards RT, Slevin N. Randomised feasibility study to compare the use of Therabite(R) with wooden spatulas to relieve and prevent trismus in patients with cancer of the head and neck. Br J Oral Maxillofac Surg. 2018 May;56(4):283-291. doi: 10.1016/j.bjoms.2018.02.012. Epub 2018 Mar 9.
PubMed 29526341
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Pilot Study of Therabite® Versus Wooden Spatula in the Amelioration of Trismus in Head and Neck Cancer Patients. (Trismus Trial)
- ClinicalTrials.gov ID
- NCT01733797
- Acronym / sponsor ID
- 09DOG0843
- Conditions
- Oropharyngeal Cancer, Oral Cancer
- Keywords
- Trismus, Therabite, Wooden spatula, Head and Neck cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Brynn ChappellUniversity, hospital or other
- Collaborators
- The Christie NHS Foundation Trust
- Study start
- Dec 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial will compare exercises using Therabite® versus wooden spatulas to prevent or relieve trismus in patients with stage 3 and 4 oral/oropharyngeal cancer.
Detailed description
Trismus is defined as a tightening of jaw opening. The negative impact of Trismus on the quality of life of head and neck cancer patients is well established. It affects eating, drinking, speaking and social function and is often as debilitating as any disfigurement resulting from treatment.
The use of jaw exercises using a Therabite appliance following treatment has been shown to reduce the level of Trismus in small studies. Many UK centres, however, use stacked wooden spatulas inserted between the incisors as a means of passive exercise. There is anecdotal evidence that suggests the use of exercises prior to treatment may help reduce the severity of the Trismus experienced by the patient.
This study will enrol 112 head and neck cancer patients allocated by chance to use either the Therabite or wooden spatula and patients will be asked to perform mouth exercises on a daily basis for 6 months.
There is a need to evaluate both the clinical effectiveness and cost-effectiveness of Therabite as opposed to wooden spatulas to determine whether they should be adopted as standard care in head and neck cancer patients.
In this pilot trial, the investigators will measure benefits of Therabite to patients, as compared to usual care with wooden spatulas. Mouth opening will be the key outcome for the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wooden spatula | Experimental | Device: Wooden spatula |
| Therabite | Experimental | Device: Therabite |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed, written informed consent
- Aged 18 years and older
- Able to read and write English sufficiently to be able to complete questionnaires
- Stage 3/4 oral and oropharyngeal cancer patients undergoing:
- Primary chemoradiotherapy or Surgical free flap plus post operative radiotherapy or post operative chemoradiotherapy
Key exclusion criteria (6 listed)
- <12mm mouth opening (cannot use Therabite)
- Anatomically unable to use Therabite for example patients who may only be partially dentate and to use the Therabite would place extreme stress on the existing teeth
- Cognitive impairment as judged by the clinicians
- International patients treated who will not have routine UK follow up.
- Previous surgery or RT to the head and neck prior to this diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wooden spatulaLollipop sticks placed between incisors | Device | Wooden spatula |
| TherabiteHand held device placed in mouth that exercises the jaw | Device | Therabite |
Primary outcome
Change in Jaw measurement
Time frame: Baseline, 3 months and 6 months at hopsital
Willis bite calliper will be used to measure the jaw opening at baseline, 3 and 6 months
3 secondary outcomes
Adherence to intervention
Time frame: up to 6 months
Quality of Life
Time frame: Baseline, 3 and 6 months
Health economic analysis
Time frame: Baseline, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
- Derived from this study: PubMed 29602860Lee R, Molassiotis A, Rogers SN, Edwards RT, Ryder D, Slevin N. Protocol for the trismus trial-therabite versus wooden spatula in the amelioration of trismus in patients with head and neck cancer: randomised pilot study. BMJ Open. 2018 Mar 30;8(3):e021938. doi: 10.1136/bmjopen-2018-021938.
- Derived from this study: PubMed 29526341Lee R, Yeo ST, Rogers SN, Caress AL, Molassiotis A, Ryder D, Sanghera P, Lunt C, Scott B, Keeley P, Edwards RT, Slevin N. Randomised feasibility study to compare the use of Therabite(R) with wooden spatulas to relieve and prevent trismus in patients with cancer of the head and neck. Br J Oral Maxillofac Surg. 2018 May;56(4):283-291. doi: 10.1016/j.bjoms.2018.02.012. Epub 2018 Mar 9.
- Christie NHS websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Slevin study chair
The Christie NHS Foundation Trust
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Wooden spatula and Therabite in people with Oropharyngeal Cancer and Oral Cancer, run by Brynn Chappell at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Jaw measurement (time frame: Baseline, 3 months and 6 months at hopsital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01733797, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.