Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients
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.
Device: Wooden spatula
|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)|
- 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
- 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
|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)|
|Experimental: Wooden spatula||
Device: Wooden spatula
Lollipop sticks placed between incisors
Hand held device placed in mouth that exercises the jaw
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|