Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at a 9 week exercise programme to improve fitness after chemoradiotherapy for rectal cancer
This trial is looking at whether a 9 week exercise programme can improve the fitness of people with cancer of the back passage (rectum) after having chemoradiotherapy. The trial is open to people who have rectal cancer that has started to grow into the surrounding tissue (locally advanced).
Doctors often give a combination of chemotherapy with radiotherapy (chemoradiotherapy) to people with locally advanced rectal cancer before they have surgery. This is to shrink the cancer and make it easier to take out.
We know that chemoradiotherapy can lower your physical fitness level. The researchers think that a short period of exercise after chemoradiotherapy may help improve fitness levels. They also think this could help people recover better and more quickly after surgery.
The aims of this trial are to find out if
- Exercise can improve fitness levels and
quality of lifeafter chemoradiotherapy
- Improving physical fitness before surgery can reduce complications afterwards
Who can enter
You may be able to enter this trial if you are attending the Aintree University Hospitals NHS Foundation Trust or University Hospital Southampton NHS Foundation Trust and you
- Have cancer of the
- Are to have chemoradiotherapy before surgery to remove your cancer
This is a phase 2 trial. It will recruit 46 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.
You will have chemotherapy with radiotherapy (chemoradiotherapy) before surgery to remove your rectal cancer. You have surgery between 9 and 14 weeks after finishing chemoradiotherapy.
People in group 1 have supervised exercise sessions at the hospital. You have 3 exercise sessions a week for up to 9 weeks. That makes a total of 27 exercise sessions. Each session is 30 to 40 minutes on an exercise bike.
People in group 2 are given standard advice on exercise. You will not attend any exercise sessions.
The researchers will ask you to fill in 3 quality of life questionnaires
- When you agree to take part in the trial
- After your chemoradiotherapy
- A number of times before having surgery
- 4 to 6 weeks after surgery
They will ask how you have been and about any side effects you might have. The researchers will also ask to interview you after finishing chemoradiotherapy and again 9 weeks later. They will ask you about your experience with the exercise programme and about any side effects you may have. These are called quality of life studies.
The research team wants to find out how much physical activity you normally do and how this changes due to your treatment. To do this they will ask you to wear a device called an accelerometer. This is like a small arm band you wear on your upper arm (under your clothing).
You wear the accelerometer for 3 days at a time
- Before having chemoradiotherapy
- At the end of your chemoradiotherapy
- A number of times after finishing chemoradiotherapy – the trial team will tell you more about this
You will have your fitness tested at various times during the trial. The researchers will ask to take a blood sample before and after each of these fitness tests. They will look for substances in your blood that can measure how the exercise is affecting you.
Your muscles may feel sore after the exercise sessions but this should only last a day or 2.
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.
Dr Sandy Jack
Aintree University Hospitals NHS Foundation Trust
NIHR Research for Patient Benefit (RfPB) Programme
University Hospital Southampton NHS Foundation Trust