Clinical trial NCT01733797: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oropharyngeal Cancer
Oral Cancer
Keywords: Trismus
Therabite
Wooden spatula
Head and Neck cancer
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: The Christie NHS Foundation Trust
First posted: 2012-11-27
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Jaw measurement
timeFrame: Baseline, 3 months and 6 months at hopsital
Secondary outcomes:
measure: Adherence to intervention
timeFrame: up to 6 months
measure: Quality of Life
timeFrame: Baseline, 3 and 6 months
measure: Health economic analysis
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: East Grinstead
country: United Kingdom
facility: Queen Victoria Hospital
city: Liverpool
country: United Kingdom
facility: Aintree University Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: York
country: United Kingdom
facility: York Hospital
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Prof Slevin
role: STUDY_CHAIR
References:
citation: Lee R, Molassiotis A, Rogers SN, Edwards RT, Ryder D, Slevin N. Protocol for the trismus trial-therabite versus wooden spatula in the amelioration of trismus in patients with head and neck cancer: randomised pilot study. BMJ Open. 2018 Mar 30;8(3):e021938. doi: 10.1136/bmjopen-2018-021938.
citation: Lee R, Yeo ST, Rogers SN, Caress AL, Molassiotis A, Ryder D, Sanghera P, Lunt C, Scott B, Keeley P, Edwards RT, Slevin N. Randomised feasibility study to compare the use of Therabite(R) with wooden spatulas to relieve and prevent trismus in patients with cancer of the head and neck. Br J Oral Maxillofac Surg. 2018 May;56(4):283-291. doi: 10.1016/j.bjoms.2018.02.012. Epub 2018 Mar 9.