A study looking at diet and exercise for people with chronic lymphocytic leukaemia (HIIT-CLL STUDY)
Cancer type:
Status:
Phase:
This study is looking at whether diet and exercise can improve the health of people with chronic lymphocytic leukaemia (CLL).
Doctors know that people with cancer can benefit from a healthy diet and exercise. But most of the research so far has been in people who have a 
and not a blood cancer such as CLL. So doctors are not sure if there is the same benefit for people with CLL.
Everyone in this study has CLL. The team will compare people who do exercise with people who don’t exercise. The main aim of the study is to find out whether exercise and a healthy diet improves the health of people with CLL.
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 chronic lymphocytic leukaemia (CLL). This includes small lymphocytic lymphoma (SLL).
- are able to walk on a treadmill or cycle on an exercise bike
- are physically fit enough and well enough to take part. You fill in 2 questionnaires to find this out.
- are able to understand spoken and written English
- are at least 18 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- started taking
steroids less than 7 days before joining the study. This is apart from a small dose of steroids, inhalers and creams. - have had another cancer within the past 3 years that needed treatment. This is apart from
non melanoma skin cancer , carcinoma in situ of the cervix, non muscle invasive bladder cancer that has not been treated with either chemotherapy or BCG into the bladder in the 6 months before joining this trial, prostate cancer that is contained in the prostate gland and your PSA is stable. - have
heart problems such as heart failure or a heart attack in the past 6 months - have an infection that affects your whole body
- have problems with your joints, bones or muscles
- have type 1 diabetes or you have type 2 diabetes that isn’t controlled
- have high blood pressure that isn’t controlled
- have chronic obstructive pulmonary disease (COPD)
- have HIV, hepatitis B or hepatitis C
- have any other medical conditions or mental health problems that could affect you taking part in the study
Trial design
The study team are inviting people to take part by email via an organisation called CLL Support. You can reply to the study team by email if you are interested. You can ask your CLL doctor or nurse specialist about the study if you are interested.
The team need 132 people to take part.
When you agree to join the study, you fill in:
- a questionnaire about your medical history
- the physical activity readiness questionnaires (PAR-Q+)
Answering the questions will help you and the team decide whether you will need to get medical permission to take part. If you do, the study team will contact your health provider to ask permission. This could be your GP or your CLL doctor at the hospital.
There are 3 groups in this study, 2 exercise groups and a control group. A computer puts you into 1 of the 3 groups at random. The groups are:
- HIIT exercise group
- EXE+ exercise group
- CON
control group
HIIT
In this group you do exercise to improve your health and fitness. You do 3 exercise sessions 3 times a week for 12 weeks. Each session takes 30 to 60 minutes. The exercise includes aerobic exercises such as walking and cycling, as well as strength exercises such as using weights, resistance bands or body-weight workouts.
Each session will vary. You might do one continuous exercise for the session or you might do a short burst of different exercises during the session.
After the initial 12 weeks, the team will assess your fitness. They will then encourage you to continue with the exercises for another 12 weeks without supervision.
After the further 12 weeks, the team will invite you back to assess your fitness again. You don’t have to agree to do either the further 12 weeks of exercise or the fitness assessment after.
EXE+
In this group you do the same exercise sessions as the HIIT group for 12 weeks. You also get advice on your diet. You fill in a weekly food diary.
The study team will look at your diet and give you advice on how to have a healthy diet. For example this could include:
- increasing the number of different types of protein and the amount of protein
- reducing the amount of refined sugar by drinking less sugary drinks
- increasing the amount of fibre by eating wholegrain foods such as wholegrain cereals
After the initial 12 weeks the team will assess your fitness. They will then encourage you to continue with the exercises for another 12 weeks without supervision.
After these further 12 weeks the team will invite you back to assess your fitness again. You don’t have to agree to do either the further 12 weeks of exercise or the fitness assessment after.
CON
In this group the team give you written information about physical activity and diet recommendations from the UK Government. They will also give you information about how to achieve these recommendations.
After 12 weeks the team will invite you to take part in the exercises that those in the HIIT and EXE+ did. This is because the study team think that the exercises will be beneficial. You don’t have to agree to this.
For people in the HIIT and EXE+ groups
If you go into the HIIT or EXE+ group, the team will ask whether you want to be in:
- the supervised group called ENERGIZE or
- the semi supervised group called REMOTE
ENERGIZE
In this group you go to the University of Surrey 3 times a week for your exercise sessions. A member of the study team will supervise your exercise sessions. They will organise the sessions around your day to make sure it best suits you.
REMOTE
In this group you do your 3 exercise sessions a week where it is convenient for you such as your home or a gym. The study team will semi supervise you. This means you have a video call from a member of the study team. During the call they give detailed guidance about your exercises and what you need to do in each session. They will also set out a weekly exercise plan for you.
The team will contact you at times during the 12 weeks. This could be daily or weekly. This is to make sure you are doing the exercises as you should be doing them.
Questionnaires
You fill in questionnaires at the start and end of the study.
The questions ask about your:
quality of life - physical activity
- mental and emotional wellbeing
Hospital visits
There are no hospital visits in this study.
A member of the study team will contact you. They will discuss the study with you and ask questions to find out if you are able to join. You can do this either:
- in person at the University of Surrey
- as a video call or
- as a phone call
You have 3 assessment days at the Surrey Human Performance Institute. The institute is in the Surrey Sports Park, Guildford.
Assessment day 1
In the 24 hours before this day you cannot do any energetic or active sport such as tennis, running or swimming. The team will ask you not to eat after going to bed the night before. You can drink, but only water. You bring your breakfast with you. You will have your breakfast during the tests.
You will be at the Surrey Human Performance Institute for about 2 hours for various assessments and tests. The first tests are:
- body composition. This looks at your height, weight and the amount of fat in the body.
- resting metabolic rate. This looks at the amount of energy your body needs.
- muscle health. This looks at how much energy or power your muscles have and how much oxygen is in the muscles.
- resting heart trace. This is an electrocardiogram (ECG). It records your heartbeat and heart rhythm.
- a blood test
Before the next set of tests, you can have your breakfast if you want. These tests are:
- physical performance. This looks at your balance and how well you can do everyday physical activities.
- aerobic fitness. This looks at how fit you are. From this the team can work out what level of exercise to give you. You try out different exercises such as cycling or walking. The team will ask which type of exercise you prefer.
- muscle strength. This looks at how strong your upper body and leg muscles are. You use weight machines to find this out.
Before going home, the team will arrange the date and time for you to come for the next 2 assessment days.
Assessment day 2
In the 24 hours before this day you cannot do any energetic or active sport such as tennis, running or swimming. The team will ask you not to eat after going to bed the night before. You can drink, but only water. You bring your breakfast with you. You can have your breakfast after the test.
This test looks at how your immune system responds to stress. The team take a blood sample. You do a 30 minute exercise session. After the exercise session you sit down and rest for 30 minutes. The team then take another blood sample.
You can drink water before, during and after the exercise session.
The whole assessment takes 1 hour and 30 minutes.
Assessment day 3
In the 24 hours before this day you cannot do any energetic or active sport such as tennis, running or swimming. The team will ask you not to eat after going to bed the night before. You can drink, but only water. You can bring food with you to eat after the test and something to entertain yourself such as a book.
This test looks at where the energy from your food goes. The team will explain the test to you. They take a blood sample. You then eat breakfast provided by the team and drink a milkshake containing fatty acids and olive oil. You remain seated for 3 hours and then the team take another blood sample. After this you are free to go home.
Further assessment days
The team will ask you back to have the same assessments again if you continue the further 12 weeks of exercise. They will tell you more about this when they discuss the study with you.
Side effects
The study team monitor you during the study. You can discuss with the team any concerns or problems you may have.
There might be some unknown risks or discomforts that the team are not aware of. The known risks of taking part in an exercise programme include:
- sore muscles, joints and bones
- shortness of breath
- tiredness
The risks of having a blood test includes:
- discomfort
- bleeding
- bruising
The team will discuss with you the possible risks of taking part in the study. They will answer any questions you have before you agree to take part.
We have more information about:
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
Dr David Bartlett
Supported by
American Society of Hematology
University of Surrey
CLL support
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
