Clinical Trial
A clinical trial is a scientific way of testing new medicines, treatments or new ways of doing things. People volunteer to take part in the trial and researchers watch closely to see how well it works. Clinical trials have to be approved by the authorities before they can start to make sure that they are safe for the participants.
The goals of the PRE-ACT clinical trial
In the PRE-ACT project, we are creating a tool ('the app') to predict the chance of side effects of radiotherapy treatment for patients with breast cancer, including arm swelling. The tool will predict this risk for each individual patient. If the tool shows that someone has a high chance of arm swelling, they will be offered a special sleeve, designed to help with the swelling. With the clinical trial, we want to show that using this tool, and sometimes the sleeve, keeps the level of arm swelling the same or less as regular treatment without the tool does. This means that we want to make sure that the new treatment, in this case the tool, works without causing any harm.
Check whether it is really a feasible study
In the trial, we will also check other important things. We will look at the decisions that patients make about their treatment and whether those change when the tool is used. Also, we will ask the participants about their quality of life to see if this changes when using the tool.
How will the clinical trial be run?
The trial will take place in hospitals in France, the United Kingdom and in The Netherlands. Doctors will ask patients to participate in the trial. We will divide the patients randomly into two groups: a control group and an intervention group. Patients in the control group will receive standard advice and care. Those in the treatment group will be informed about their risk of lymphedema based on the prediction tool. Patients in both groups will be able to choose to wear the special compression sleeve to help with the swelling. We need these two groups so that we can compare them to each other and see if there are differences between them.
Who can take part?
In principle, any female breast cancer patient from any of the registered hospitals can participate. But there are so-called inclusion and exclusion criteria. Such as patients who have undergone surgery and need extra radiotherapy. You can read al the criteria here. It is best if you ask your doctor about these criteria. He/she can also provide you with the right information.
Patients who want to participate must complete a number of questionnaires at intake, after three months of treatment, after 1 year and after 2 years. You will also - optionally - be asked to donate 2 tubes of blood. Please note that this is not compulsory. You can also participate without the blood donation.
At this moment the participating hospitals are not yet known. We will publish their names as soons as possible.