Condition category
Cancer
Date applied
25/10/2012
Date assigned
26/10/2012
Last edited
11/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Colin Lunt

ORCID ID

Contact details

Christie Hospital
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
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.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13415

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 measures

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

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
Manchester
M20 4BX
United Kingdom

Sponsor information

Organisation

Christie Hospital NHS Foundation Trust (UK)

Sponsor details

550 Wilmslow Road
Manchester
M20 4BX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes