Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients
|ClinicalTrials.gov Identifier: NCT01733797|
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : October 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Oropharyngeal Cancer Oral Cancer||Device: Wooden spatula Device: Therabite||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Wooden spatula||
Device: Wooden spatula
Lollipop sticks placed between incisors
Hand held device placed in mouth that exercises the jaw
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733797
|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, United Kingdom, YO31 8HE|
|Study Chair:||Prof Slevin||The Christie NHS Foundation Trust|