"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 a care package for people having chemoradiotherapy for cervical cancer or bladder cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at providing a package of care (care bundle) for people having chemoradiation for cancer of the cervix (cervical cancer) or bladder cancer.
Doctors can use a combination of chemotherapy and radiotherapy (
The researchers think that a care bundle might help people who are having bowel side effects during radiotherapy. If it does, it may improve their quality of life and help them to complete their treatment.
The aim of this study is to see if using the care bundle could help improve bowel side effects caused by radiotherapy and so improve people’s quality of life.
Who can enter
This is a pilot study. It will recruit 60 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
There are 2 groups in this trial. People in group 1 have standard treatment. People in group 2 have standard treatment plus the care bundle.
During radiotherapy, people in group 1 will see the doctor as usual to see if they have any problems with eating or drinking. If you develop any side effects, for example diarrhoea, they will give you medication for it.
During radiotherapy, people in group 2 will see a specialist cancer
The first is to see if you are not able to digest a sugar found in dairy products (lactose intolerant). You cannot eat or drink anything, apart from water, for 12 hours before the test. You blow into a small tube for a few seconds and a sample of your breath is collected.
The second is to see if there are too many bacteria in your small bowel. A sample of your breath is collected in the same way as in the first test. You then have a sugar drink and a sample of your breath is taken at regular times over 2 to 3 hours.
The third is to see if your body is absorbing enough bile. You take a small tablet that gives off energy particles or waves (radiation) that can be seen on a scan. You have a scan on the day you take the tablet and then another scan 5 to 7 days later.
If the result of any of these tests is positive, you will start medication.
The trial team will ask you to fill out a questionnaire before you start treatment, during treatment and after your treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Before starting treatment everyone is seen by the doctor or a specialist dietician to look at what you are eating and drinking.
Those people who see the dietician will also have the following tests to find out how good their diet is. A test
- Of the strength of your hand grip
- To find out how much fat is in your body
During radiotherapy, you see the doctor or dietician weekly.
After radiotherapy, everyone will see the doctor at 1 week, 3 months and 1 year. People in group 2 will also see the dietician.
The researchers don’t anticipate any major side effects if you take part in this study. You may feel slightly dizzy or sick after some of the tests.
We have more information about the side effects of radiotherapy to your stomach and the area between your hips (pelvis).
How to join a clinical trial
Dr Susan Davidson
NIHR Clinical Research Network: Cancer
NIHR Research for Patient Benefit (RfPB) Programme
The Christie NHS Foundation Trust