"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study looking at using exercises before radiotherapy to help reduce mouth opening problems in head and neck cancer patients (Open Wide)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is trying to find out whether using an exercise programme before radiotherapy will reduce the risk of mouth opening problems in people with head and neck cancer.
Doctors may use radiotherapy or
This can lead to problems opening your mouth properly (
People who develop trismus after their treatment are often shown how to do exercises to gently open and stretch the jaw. One way to do this is with the Therabite device. You hold the handle of this device in your hand and the other part between your teeth. You squeeze the handle for a few seconds, then release it. This gently moves the jaw joint and stretches the muscles.
Researchers think that these exercises might be useful for people to do before they start treatment. The aims of this study are to find out
- If patients will use the Therabite during and after their radiotherapy
- Whether exercise before treatment will reduce problems with mouth opening
Who can enter
You may be able to join this study if you have head and neck cancer such as
- You are due to have radiotherapy or
- You are due to have radiotherapy to your jaw joint (where the jawbone joins the skull) or the muscles surrounding this joint
- Are asked to take part by your doctor
This is a pilot study. The researchers need 20 people to join the trial.
Before you start radiotherapy you see the Speech and Language Therapist. They will show you how to use the Therabite device to do your jaw stretching exercises.
You put the Therabite between your teeth and squeeze the handle for 7 seconds, then release. You repeat this movement up to 7 times. This takes about 1 minute. The trial team will ask you to do this 7 times a day if possible. They will also ask you to keep a record of when you do the exercises.
The trial team will ask you to fill out various questionnaires before you start cancer treatment, 3 months later and at the end of the study. These questionnaires will ask you about your speech, swallowing and chewing, whether you have any problems and how much they affect your everyday life. This is called a quality of life study.
At the end of the study, you are encouraged to continue using the exercises as long as you are finding them useful. The trial team will continue to support you with this.
The researcher will treat everything you tell them
You go to hospital to see the Speech and Language Therapist (SLT) before you start treatment. This is an extra visit you have as a result of taking part in this study.
The therapist will ask you questions about what you can eat and drink. They will also measure your jaw movement and how far you can open your mouth.
You see the therapist once a month for 6 months during your routine head and neck clinic appointments. At each visit you have more measurements and the therapist will ask you how you are getting on with your exercises.
After 6 months you have one final appointment as part of this study. The trial team would like to know what you think about this study.
You have to do the exercises quite frequently throughout the day. Some people may be find this difficult or inconvenient.
The exercises using the Therabite may cause discomfort. If this happening, do contact the Speech and Language Therapist. They may be able to suggest ways to make the exercises more comfortable.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Ms Menna Payne
Cam Taf Univeristy Hospital Health Board