Brief Title
Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients
Official Title
Randomised Pilot Study of Therabite® Versus Wooden Spatula in the Amelioration of Trismus in Head and Neck Cancer Patients. (Trismus Trial)
Brief 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.
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Change in Jaw measurement
Secondary Outcome
Adherence to intervention
Condition
Oropharyngeal Cancer
Intervention
Wooden spatula
Study Arms / Comparison Groups
Wooden spatula
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
71
Start Date
December 2012
Completion Date
August 2015
Primary Completion Date
August 2015
Eligibility Criteria
Inclusion Criteria: - 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. Exclusion Criteria: - <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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Prof Slevin, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT01733797
Organization ID
09DOG0843
Secondary IDs
ISRCTN79084153
Responsible Party
Sponsor-Investigator
Study Sponsor
Brynn Chappell
Collaborators
The Christie NHS Foundation Trust
Study Sponsor
Prof Slevin, Study Chair, The Christie NHS Foundation Trust
Verification Date
September 2015