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

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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