Contact information
Type
Scientific
Primary contact
Mr Colin Lunt
ORCID ID
Contact details
Christie Hospital
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
+44 161 446 3000
colin.lunt@christie.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01733797
Protocol/serial number
13415
Study information
Scientific title
Trismus RfPB trial: A randomised pilot study of TheraBite® use versus wooden spatula in the amelioration of trismus in head and neck cancer patients
Acronym
Study hypothesis
Trismus is 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 enroll 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 with either the Therabite or wooden spatula prior to and throughout their treatment. A review of the literature has suggested that use of passive mouth exercises could improve maximum mouth opening and hence QOL for these patients. Mouth opening will be the key outcome for the study measured over the time of treatments.
There is a need to evaluate both the effectiveness and cost-effectiveness of TheraBite® as opposed to wooden spatulas to evaluate whether they should be adopted as standard care in head and neck cancer patients. In this pilot trial, we will look at how well various questionnaires help us measure benefits of the TheraBite® to patients, as compared to usual care with wooden spatulas.
Ethics approval
NRES Committee North West - Greater Manchester North, First MREC approval date 01/06/2012, ref: 12/NW/0414
Study design
Randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Trismus in head and neck cancer patients
Intervention
TheraBite® is intended for use in individuals who are restricted in their ability to open their jaws (trismus or jaw hypomobility)
Wooden spatula, Wooden lollipop shaped sticks
Follow Up Length: 6 month(s)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Maximum mouth opening recorded daily
Secondary outcome measures
1. Patient compliance and tolerability measured at 3 and 6 months
2. Quality of Life and Health Economic outcome at baseline, 3 and 6 months
Overall trial start date
23/11/2012
Overall trial end date
25/06/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Provision of signed, written informed consent
2. Aged 18 years and older
3. Able to read and write English sufficiently to be able to complete questionnaires
4. Stage 3/4 oral and oropharyngeal cancer patients undergoing primary chemoradiotherapy or surgical free flap
pluspost operative radiotherapy or post operative chemoradiotherapy
5. All patients will receive 60-70 Gy in 30-35 fractions over 6 to 7 weeks to the region of the pterygoid muscles
6. All patients will have at least some trismus as indicated by subjective tightening in the jaw
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 112; UK Sample Size: 112
Participant exclusion criteria
1. <12mm mouth opening (cannot use TheraBite®)
2. 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
3. Cognitive impairment as judged by the clinicians
4. International patients treated who will not have routine UK follow up
5. Previous surgery or radiotherapy (RT) to the head and neck prior to this diagnosis
6. Any patient who has no subjective tightening of the jaw
Recruitment start date
23/11/2012
Recruitment end date
25/06/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Christie Hospital
550 Wilmslow Rd
Manchester
M20 4BX
United Kingdom
Funders
Funder type
Government
Funder name
NIHR (UK) - Central Commissioning Facility (CCF)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29602860 (added 10/04/2019)
2. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/29526341 (added 10/04/2019)