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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Christie Hospital NHS Foundation Trust
Sponsor:
Collaborator:
Christie Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Colin Lunt, Christie Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01733797
First received: November 19, 2012
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Oropharyngeal Cancer
Oral Cancer
Device: Wooden spatula
Device: Therabite
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Christie Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Change in Jaw measurement [ Time Frame: Baseline, 3 months and 6 months at hopsital ] [ Designated as safety issue: No ]
    Willis bite calliper will be used to measure the jaw opening at baseline, 3 and 6 months


Secondary Outcome Measures:
  • Adherence to intervention [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Adherence to device use will be captured by the patient on a progress log

  • Quality of Life [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Health economic analysis [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 112
Study Start Date: December 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733797

Contacts
Contact: Colin Lunt +44 (0) 161 918 7492 colin.lunt@christie.nhs.uk

Locations
United Kingdom
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B15 2TH
Principal Investigator: Paul Sanghera         
Queen Victoria Hospital Recruiting
East Grinstead, United Kingdom, RH19 3DZ
Principal Investigator: Brian Bisase         
Aintree University Hospitals NHS Foundation Trust Recruiting
Liverpool, United Kingdom, L9 7AL
Principal Investigator: Simon Rogers         
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
Principal Investigator: Nick Slevin         
York Hospital Recruiting
York, United Kingdom, YO31 8HE
Principal Investigator: Andrew Coatesworth         
Sponsors and Collaborators
Colin Lunt
Christie Hospital NHS Foundation Trust
Investigators
Study Chair: Prof Slevin The Christie NHS Foundation Trust
  More Information

Additional Information:
No publications provided

Responsible Party: Colin Lunt, Clinical Trials Project Manager, Christie Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01733797     History of Changes
Other Study ID Numbers: 09DOG0843, ISRCTN79084153, PB-PG-0610-22317
Study First Received: November 19, 2012
Last Updated: June 11, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Christie Hospital NHS Foundation Trust:
Trismus
Therabite
Wooden spatula
Head and Neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mouth Neoplasms
Trismus
Oropharyngeal Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014