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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01733797
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : October 1, 2015
The Christie NHS Foundation Trust
Information provided by (Responsible Party):
Brynn Chappell, The Christie NHS Foundation Trust

November 19, 2012
November 27, 2012
October 1, 2015
December 2012
August 2015   (Final data collection date for primary outcome measure)
Change in Jaw measurement [ Time Frame: Baseline, 3 months and 6 months at hopsital ]
Willis bite calliper will be used to measure the jaw opening at baseline, 3 and 6 months
Same as current
Complete list of historical versions of study NCT01733797 on Archive Site
  • Adherence to intervention [ Time Frame: up to 6 months ]
    Adherence to device use will be captured by the patient on a progress log
  • Quality of Life [ Time Frame: Baseline, 3 and 6 months ]
  • Health economic analysis [ Time Frame: Baseline, 3 and 6 months ]
    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
Same as current
Not Provided
Not Provided
Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients
Randomised Pilot Study of Therabite® Versus Wooden Spatula in the Amelioration of Trismus in Head and Neck Cancer Patients. (Trismus Trial)
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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Oropharyngeal Cancer
  • Oral Cancer
  • Device: Wooden spatula
    Lollipop sticks placed between incisors
  • Device: Therabite
    Hand held device placed in mouth that exercises the jaw
  • Experimental: Wooden spatula
    Intervention: Device: Wooden spatula
  • Experimental: Therabite
    Intervention: Device: Therabite
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2015
August 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
ISRCTN79084153 ( Registry Identifier: ISRCTN )
PB-PG-0610-22317 ( Other Grant/Funding Number: NIHR Research for Patient Benefit )
Not Provided
Not Provided
Brynn Chappell, The Christie NHS Foundation Trust
Brynn Chappell
The Christie NHS Foundation Trust
Study Chair: Prof Slevin The Christie NHS Foundation Trust
The Christie NHS Foundation Trust
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP