Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients

Oral Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733797
• Other study ID #: 09DOG0843
• Secondary ID: ISRCTN79084153PB
• Status: Completed
• Phase: Phase 2
• First received: November 19, 2012
• Last updated: September 30, 2015
• Start date: December 2012
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Christie Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Oral Cancer
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms
• Trismus

Intervention

Device:
• Wooden spatula
Lollipop sticks placed between incisors
• Therabite
Hand held device placed in mouth that exercises the jaw

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Queen Victoria Hospital	East Grinstead
United Kingdom	Aintree University Hospitals NHS Foundation Trust	Liverpool
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	York Hospital	York

Sponsors (2)

Lead Sponsor	Collaborator
Brynn Chappell	Christie Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Jaw measurement	Willis bite calliper will be used to measure the jaw opening at baseline, 3 and 6 months	Baseline, 3 months and 6 months at hopsital	No
Secondary	Adherence to intervention	Adherence to device use will be captured by the patient on a progress log	up to 6 months	No
Secondary	Quality of Life		Baseline, 3 and 6 months	No
Secondary	Health economic analysis	Patients hospital and service use will be captured at Baseline, 3 and 6 months during interviews with the patient.; Units used will be days in hospital or number of appointments	Baseline, 3 and 6 months	No

External Links

•   Christie NHS website