Trismus in head and neck cancer patients Cancer Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx
Conditions
Interventions
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
Sponsors
Christie Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum mouth opening recorded daily | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed