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

September 30, 2015 updated by: Brynn Chappell

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • East Grinstead, United Kingdom, RH19 3DZ
        • Queen Victoria Hospital
      • Liverpool, United Kingdom, L9 7AL
        • Aintree University Hospitals NHS Foundation Trust
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
      • York, United Kingdom, YO31 8HE
        • York Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Wooden spatula
Device: Wooden spatula
Lollipop sticks placed between incisors
EXPERIMENTAL: Therabite
Device: Therabite
Hand held device placed in mouth that exercises the jaw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 3 months and 6 months at hopsital

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to intervention
Time Frame: up to 6 months
Adherence to device use will be captured by the patient on a progress log
up to 6 months
Quality of Life
Time Frame: Baseline, 3 and 6 months
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
Baseline, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brynn Chappell

Collaborators

The Christie NHS Foundation Trust

Investigators

  • Study Chair: Prof Slevin, The Christie NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

November 19, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (ESTIMATE)

November 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09DOG0843
  • ISRCTN79084153 (REGISTRY: ISRCTN)
  • PB-PG-0610-22317 (OTHER_GRANT: NIHR Research for Patient Benefit)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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