Trismus RfPB trial: TheraBite® versus wooden spatula in the amelioration of trismus in head and neck cancer patients

ISRCTN	ISRCTN79084153
DOI	https://doi.org/10.1186/ISRCTN79084153
ClinicalTrials.gov number	NCT01733797
Secondary identifying numbers	13415

Submission date: 25/10/2012
Registration date: 26/10/2012
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-comparing-wooden-spatulas-therabite-device-head-neck-cancer-patients-mouth-opening-problems-trismus-trial

Contact information

Mr Colin Lunt
Scientific

Christie Hospital
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom

Phone	+44 161 446 3000
Email	colin.lunt@christie.nhs.uk

Study information

Study design	Randomised controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	NRES Committee North West - Greater Manchester North, First MREC approval date 01/06/2012, ref: 12/NW/0414
Health condition(s) or problem(s) studied	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
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 study start date	23/11/2012
Completion date	25/06/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 112; UK Sample Size: 112
Total final enrolment	71
Key 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
Key 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
Date of first enrolment	23/11/2012
Date of final enrolment	25/06/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Christie Hospital

550 Wilmslow Rd
Manchester
M20 4BX
United Kingdom

Sponsor information

Christie Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

550 Wilmslow Road
Manchester
M20 4BX
England
United Kingdom

"ROR"	https://ror.org/03v9efr22

Funders

Funder type

Government

NIHR (UK) - Central Commissioning Facility (CCF)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	30/03/2018	10/04/2019	Yes	No
Results article	results	01/05/2018	10/04/2019	Yes	No
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
10/04/2019: Publication reference added.
13/01/2017: No publications found in PubMed, verifying study status with principal investigator.