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

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ClinicalTrials.gov Identifier: NCT01733797
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : October 1, 2015
Sponsor:
Collaborator:
The Christie NHS Foundation Trust
Information provided by (Responsible Party):
Brynn Chappell, The Christie NHS Foundation Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oropharyngeal Cancer Oral Cancer Device: Wooden spatula Device: Therabite Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomised Pilot Study of Therabite® Versus Wooden Spatula in the Amelioration of Trismus in Head and Neck Cancer Patients. (Trismus Trial)
Study Start Date : December 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Adherence to intervention [ Time Frame: up to 6 months ]
    Adherence to device use will be captured by the patient on a progress log

  2. Quality of Life [ Time Frame: Baseline, 3 and 6 months ]
  3. 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



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733797


Locations
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United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Queen Victoria Hospital
East Grinstead, United Kingdom, RH19 3DZ
Aintree University Hospitals NHS Foundation Trust
Liverpool, United Kingdom, L9 7AL
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
York Hospital
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Brynn Chappell
The Christie NHS Foundation Trust
Investigators
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Study Chair: Prof Slevin The Christie NHS Foundation Trust
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Brynn Chappell, Clinical Trials Project Manager, The Christie NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01733797    
Other Study ID Numbers: 09DOG0843
ISRCTN79084153 ( Registry Identifier: ISRCTN )
PB-PG-0610-22317 ( Other Grant/Funding Number: NIHR Research for Patient Benefit )
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015
Keywords provided by Brynn Chappell, The Christie NHS Foundation Trust:
Trismus
Therabite
Wooden spatula
Head and Neck cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Oropharyngeal Neoplasms
Mouth Neoplasms
Trismus
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
 Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Mouth Diseases
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases