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Randomised Pilot Study of Therabite® Versus Wooden Spatula in the Amelioration of Trismus in Head and Neck Cancer Patients. (Trismus Trial)

Phase 2
18 Years
Open (Enrolling)
Oropharyngeal Cancer, Oral Cancer

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Trial Information

Randomised Pilot Study of Therabite® Versus Wooden Spatula in the Amelioration of Trismus in Head and Neck Cancer Patients. (Trismus Trial)

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Change in Jaw measurement

Outcome Description:

Willis bite calliper will be used to measure the jaw opening at baseline, 3 and 6 months

Outcome Time Frame:

Baseline, 3 months and 6 months at hopsital

Safety Issue:


Principal Investigator

Prof Slevin

Investigator Role:

Study Chair

Investigator Affiliation:

The Christie NHS Foundation Trust


United Kingdom: Research Ethics Committee

Study ID:




Start Date:

December 2012

Completion Date:

June 2014

Related Keywords:

  • Oropharyngeal Cancer
  • Oral Cancer
  • Trismus
  • Therabite
  • Wooden spatula
  • Head and Neck cancer
  • Head and Neck Neoplasms
  • Mouth Neoplasms
  • Trismus
  • Oropharyngeal Neoplasms