A study looking at exercise for people with advanced non small cell lung cancer (EMBRACE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This is a study to see if an exercise programme before and during chemotherapy improves physical fitness in people with advanced non small cell lung cancer.
People with advanced lung cancer can have symptoms and side effects from their cancer and treatment. These can include tiredness, lack of energy and a loss of appetite. They can all affect peoples’ 
.
Exercise can help with the symptoms. So doctors often advise people to keep as active as they can during and after treatment. But doctors don’t know much about the types of exercise that are most helpful.
In this study, the researchers are testing an exercise programme before and during chemotherapy for people with advanced non small lung cancer (NSCLC).
The aims of the study are to find out:
- how helpful an exercise programme is
- if it improves physical fitness
- if there is a link between baseline fitness, how well chemotherapy works and how people do in the longer term
- if exercise training prevents a reduction in fitness
- more about how it affects quality of life
Who can enter
You may be able to join this study if all of the following apply. You
- Have non small lung cancer that has spread to
lymph nodes on the other side of your chest, into nearby body structures, or to another part of your body (stage 3B or 4) - You are having a chemotherapy drug called gemcitabine with a
platinum chemotherapy drug - You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Are at least 18 years old
You cannot join this study if any of these apply. You
- Cannot do tests where you ride an exercise bike while you have your heart and lung function measured to see how fit you are (doctors call this a cardiopulmonary exercise test or CPET for short)
- Have a significant heart problem
- Weigh more than 145kg
Trial design
This pilot study aims to recruit 100 people. It is randomised. The people taking part are put into 1 of 2 groups at random. Neither you nor your doctor will be able to decide which group you are in.
People in one group take part in the exercise training. This is called the intervention group. People in the other group do not take part in the training. This is called the control group.
If you are in the control group the researchers will give you some general information about exercising. If you are in the intervention group the exercise programme will start shortly before you have chemotherapy.
Exercise training
The researchers will plan an exercise programme based on your fitness level. It will take place at the hospital and will be a combination of riding an exercise bike, leg exercises and lifting light weights. There will also be some exercises to do at home, such as climbing stairs and brisk walking.
The exercise training programme will take up to 3 months in total. For the first 4 weeks, you go to the new exercise laboratory at the hospital twice a week. Each session takes about 30 miniutes. The staff running the study will keep a close eye on you during each session.
You then have a 2 week period of doing some exercises at the hospital and some at home. The study team will show you how to do the exercises at home. You do these for the next 6 weeks of the study. The researchers will ask you to wear a heart rate monitor when you do the exercises at home. You strap the monitor to your chest.
They will also ask you to wear a small device called an accelerometer 5 times during the study. You wear this on your upper arm for 3 days at a time. It monitors your level of activity during a typical day. It allows the researchers to see how active you are and whether this changes during your treatment.
The researchers are also interested in measuring the way your thigh muscles work during exercise. They will use a device to measure your thigh muscle strength and ask you to do some simple leg exercises.
Quality of life
The researchers will ask you to fill out 2 questionnaires at the beginning of the study, 6 weeks later and when you finish chemotherapy. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.
They will ask everyone to take part in a short interview to give your views on the study. But you don’t have to do this if you don’t want to, you can still join the study.
Samples for research
The researchers will ask a few people taking part for 3 tissue samples () taken from their thigh muscle. This is to look at muscle changes before and after chemotherapy, and after exercise training. But if you don’t want to give the samples, you don’t have to. You can still take part in the study.
Hospital visits
You see the doctor and have some tests before you can take part in study. The tests include
- Blood and urine tests
- A test to see how well your lungs are working (a lung function test)
- A test where you ride an exercise bike while you have your heart and lung function measured to see how fit you are (doctors call this a cardiopulmonary exercise test or CPET for short)
They will repeat some of the tests during the study. You have a CPET every 3 weeks for 3 months.
The researchers will try to plan the exercise programme visits around your routine hospital appointments, so that you don’t have to make extra trips to the hospital.
Side effects
You may feel achy or sore after exercise but this will settle after a day or so.
The risks of giving a tissue sample () are a very small chance of a skin infection.
CPET is safe and the researchers don’t think that there will be any side effects from this test.
Recruitment start:
Recruitment end:
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.
Chief Investigator
Dr Sandy Jack
Supported by
British Lung Foundation
British Oxygen Chair (Fit 4 Surgery Programme)
NIHR CRN National Anaesthesia Perioperative Medicine and Pain Management
NIHR Clinical Research Network: Cancer
National Institute of Academic Anaesthesia
Royal College of Anaesthetists
University Hospital Southampton NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
