A study looking at exercise and the immune system in people with oesophageal cancer (OPTIMUS)
Cancer type:
Status:
Phase:
This study is looking at immune system cells in the bloodstream and inside cancer tissue after exercise.
It is for people with cancer that started in the food pipe and has spread to surrounding tissues. This is locally advanced oesophageal cancer.
This study is for people having treatment at the Royal Surrey County hospital in Guildford.
More about this trial
Prehabilitation means getting ready for cancer treatment in whatever time you have before it starts. Exercise is part of prehabilitation.
Exercise can:
- improve people’s mental health before, during and after treatment
- improve how people cope with treatment
- reduce the amount of time they need to spend in hospital
Researchers have found that exercise training for people having treatment for breast and prostate cancer increases the amount of 
cells produced.
These immune cells travel in the bloodstream and are important in getting rid of cancer cells. But we don’t know yet if the immune cells in the bloodstream travel to the in people.
using animals has shown that exercise can increase the number of immune cells inside the tumour. And these cells work to destroy cancer cells. These cells are also called tumour infiltrating lymphocytes or TILs.
A previous carried out by this team have found evidence to suggest that:
- exercise helps the immune cells travel into the tumour
- more immune cells in the tumour means treatment is more likely to be successful and
- increased fitness means more immune cells inside the tumour
They also found that exercising a little harder can further increase your fitness and .
This study is looking at the link between exercise, the immune system and cancer treatment more closely.
To do this, the study team are comparing an existing exercise programme with a targeted exercise programme. The new programme aims to increase your level of aerobic fitness. Aerobic exercise increases your heart rate and how much oxygen your body uses. So, increasing aerobic fitness means you will be able to do more of this type of exercise and for longer. The researchers think this will increase the number of immune cells in your tumour. But they aren’t sure. They are doing this study to try and find out.
The study team will look for immune cells in the bloodstream and see what these cells are doing. They will do this before, during and after people take part in the exercise programme. They will also look at immune cells in the tumour tissue itself.
The main aims of the study are to:
- compare a moderate-high intensity exercise programme with a low intensity exercise programme during
chemotherapy and before surgery - see how the exercise programmes affects immune cells and
cytokines - look for any changes in the area around the tumour (microenvironment) after the exercise programme
- find out if there are any changes to the gut
microbiome after the exercise programme
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if all of the following apply. You:
- have oesophageal cancer that has spread to surrounding areas (locally advanced oesophageal cancer)
- are going to be having chemotherapy and then surgery
- are at least 18 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- are not able to have a test to see how your lungs, heart and muscles work together when you exercise. This is called a cardiopulmonary exercise test (CPET). Your doctor will know more.
- are not able to do exercise training safely. This might be because of bone problems or
heart problems . Your doctor will know more. - do not understand English well enough to follow the study instructions. You might be able to take part if you have a family member that can come with you to your hospital visits and interpret for you.
- are pregnant
Trial design
The researchers need 50 people to take part. They are inviting some people who are patients at the Royal Surrey County hospital. You can’t join this trial if you are not a patient at this hospital.
It is a randomised study. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 2 treatment groups.
You have 1 of the following:
- a moderate-high intensity exercise programme and chemotherapy
- a low intensity exercise programme and chemotherapy
Everyone in the study has surgery after chemotherapy. Chemotherapy and surgery is for of the food pipe (oesophageal cancer).
Everyone’s exercise programme takes between 14 and 16 weeks. You exercise alongside your chemotherapy treatment. And in the break between chemotherapy and surgery.
We have more information about what to expect during the exercise programmes in the ‘hospital visits’ part of this summary.
Chemotherapy
You have around 8 weeks of chemotherapy treatment before surgery.
Everyone has . Your treatment team will give you information on your treatment plan, including possible side effects.
Surgery
You have an 8 week break after chemotherapy and before surgery. This is so you can recover before your operation. You continue your exercise programme during this time.
Your surgical team give you information about your operation including possible side effects and how long you may be in hospital. You leave the study once you’ve had surgery.
Blood samples
You have blood tests at 3 points during the study. These are before, during and after your exercise programme.
The researchers use these samples to look at the type and number of immune cells in your blood.
Tissue samples
The study team ask to look at a sample of your cancer that was taken during your endoscopy when you were diagnosed. And they ask for a sample of your cancer from the surgery you have after chemotherapy.
The study team look at the type and number of immune cells in the samples. And look at the of the sample taken during surgery.
Poo (stool) samples
You give 3 poo samples during the study. The study team give you 3 sample containers. You collect the poo samples at home and bring one in at each of your study fitness assessments.
The study team look at any changes in your gut microbiome before, during and after your exercise programme. We know from research that the microbiome might have an impact on how well people respond to . So, the study team would like to look at any changes to the microbiome after the exercise programme.
Questionnaires
You fill in a health questionnaire before chemotherapy, after chemotherapy and before surgery. The study team can then see if anything has changed during this time.
These questionnaires ask about your:
- diet
quality of life - physical activity
medical history
Hospital visits
You have some tests before you take part in the study. These are to look at:
- your physical fitness
- how well you can do everyday activities
- your heart health
The researchers check if you have any . If you do, exercising may not be safe for you. You can’t join the study if this is the case.
You have 3 fitness assessments and 32 exercise sessions at the hospital as part of the study. You do the other exercise sessions at home.
Fitness assessments
You have a fitness assessment:
- when you join the study and before you start chemotherapy
- after your chemotherapy treatment ends
- before surgery
Each visit takes about 1.5 hours.
The tests at your fitness assessments include:
- blood tests
- height and weight - including muscle and fat mass measurements using special scales
- balance and physical tests – these include how well you can stand up from sitting down, pick things up off the floor and balance on one foot
- cardiopulmonary exercise test (CPET) – this is to see how well your heart and lungs work in terms of your fitness. It means the researchers can prescribe your exercises at the correct intensity. You cycle on an exercise bike. It starts at a low intensity and gets harder. It takes between 5 and 15 minutes depending on your fitness level. You wear a tight-fitting mask so the researchers can measure your breath. You also have 10 electrodes attached to your chest to measure your heart rate.
- muscle strength - the team will find out the strength of your arms and legs by using machine weights
After the first fitness assessment, you are put into one of the two exercise groups.
Exercise training sessions
You have 32 supervised and 48 home based exercise training sessions in total.
You have two supervised exercise sessions at the hospital per week. The study team try and make sure these are at the same time as your routine appointments. Each supervised exercise session takes around an hour.
They are designed for you specifically. You start with shorter exercises until you feel able to do more. The researchers make sure the exercises are at the right level for you. To check this, you wear:
- a heart rate monitor
- a device on your upper arm and leg to measure your muscle oxygen levels
You wear a mask every other session. This is like the one you wore for the cardiopulmonary test. This is to look at how your whole body is using oxygen.
You have a finger prick blood test before each supervised exercise session. The researchers use the results to look at:
- your
blood sugar level - lactate level – this is a substance produced when you exercise
- immune cell levels
Low intensity exercise programme
The aim of this programme is to maintain your current level of fitness.
For the aerobic part of the session, you will mostly cycle on an exercise bike. You should be able to talk during the whole session. It takes around 30 minutes each time. But this might be longer depending on your fitness level and how you are feeling.
Moderate-high intensity exercise programme
The aim of this programme is to increase your current level of fitness. For the aerobic part of the session, you will:
- cycle on an exercise bike
- walk on a treadmill if this is possible for you
You work a little harder in 1 to 2 minute bursts. And then you have 1 to 2 minutes of easy exercise after that. You might find it more difficult to talk during the harder parts. It takes around 30 minutes each time. But this might be longer depending on your fitness level and how you are feeling.
Muscle strengthening exercises (both groups)
After the aerobic part of the session, you do up to 30 minutes of muscle strengthening exercises. This might be:
- stretching with rubber resistance bands
- using a weights machine
You also do some stretching to make sure your muscles don’t feel too sore.
Home based exercise training (both groups)
Everyone taking part does an hour of home based exercise three times a week. The study team make your individual plan with you about how best to do your home based training.
Low intensity exercise programme
Your home based training focuses on:
- resistance - you complete a set of movements with lightweight resistance bands
- core strength – this is based on your level of fitness, for example you could do a seated knee lift or a plank
Moderate-high intensity exercise programme
You have an activity monitor for your workouts at home so you can see what level you are working at.
Your home based training focuses on:
- resistance - you complete a set of movements with lightweight resistance bands
- core strength – this is based on your level of fitness, for example you could do a seated knee lift or a plank
- walking or moving more – such as walking in your local park or in corridors in your home
Side effects
Possible side effects of the exercise programme include feeling sore or an injury.
Possible side effects of aerobic and muscle fitness tests include:
- shortness of breath
- tiredness (fatigue)
- your muscles feeling sore
You will be supported and monitored by highly trained staff throughout the study.
We have more information on having blood tests.
You can find your chemotherapy drugs on our cancer drugs a to z page. The pages have information about how you have the drug and possible side effects.
We have detailed information about surgery for oesophageal cancer including possible problems after surgery.
Location
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
Professor Adam Frampton
Supported by
University of Surrey
Worldwide Cancer Research Fund
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
