RecruitingNAINTERVENTIONAL

Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia

This study investigates the impact of exercise and diet on the health of adults living with chronic lymphocytic leukaemia (CLL). Participants will be randomly assigned to one of three groups for 12 weeks: an exercise-only programme, an exercise programme combined with nutritional advice, or a group that doesn't exercise. We want to see how these approaches affect physical fitness, immune system function, and other health markers. We'll collect blood samples and conduct fitness tests at the start and end of the 12 weeks. There will also be a check-up 12 weeks later to see any lasting effects. This research aims to understand if lifestyle changes can improve well-being for people with CLL. You'll need to be at least 18 years old and able to exercise.

At a glance

Status

Recruiting

Phase

Sponsor

University of Surrey

Enrolment target

132

Start

14 Oct 2022

Estimated completion

01 Aug 2026

Chronic Lymphocytic Leukemia Frailty Muscle Function Immune Function Lipid Cell; Tumor

What is this study about?

This research study is looking into how exercise and healthy eating might make a real difference for adults who have chronic lymphocytic leukaemia (CLL). CLL is a type of cancer that affects white blood cells, and we want to understand if making specific lifestyle changes can improve your overall health and well-being.

We're interested in whether a structured exercise programme, either on its own or combined with guidance on what to eat, can help improve your physical fitness, how well your immune system works, and other important aspects of your body's health. By understanding these effects, we hope to find new ways to support people living with CLL.

Participants will be randomly placed into one of three groups for 12 weeks. One group will follow an exercise programme, another will do the exercise programme and also receive nutritional guidance, and a third group won't engage in a specific exercise programme for the study. We'll then compare the results between these groups to see what benefits each approach might offer.

Key takeaways

Investigating how exercise and diet affect adults with CLL.
Participants randomly assigned to exercise, exercise + diet, or no exercise groups for 12 weeks.
Aims to improve physical fitness, immune function, and overall health.
Involves blood tests and fitness assessments.
Includes a follow-up 12 weeks after the main intervention to check lasting effects.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult aged 18 or over and have a confirmed diagnosis of chronic lymphocytic leukaemia (CLL). It's important that you are generally well enough to exercise, meaning you can walk on a treadmill or use a cycling machine comfortably, and you'll complete a simple questionnaire to check you're ready for physical activity.

There are certain reasons why you might not be able to take part. For example, if you've recently started high-dose steroid treatment, or have had another type of cancer that needed treatment in the last three years (some skin cancers and certain types of prostate cancer might be exceptions). You also can't join if you have serious heart problems, severe bone or muscle issues that stop you from exercising, or uncontrolled conditions like diabetes or very high blood pressure.

Additionally, if you have certain infections like HIV, Hepatitis B, or Hepatitis C, or if there are other reasons that would make it difficult for you to follow the study's requirements, you might not be eligible. The aim is to ensure that taking part is safe and appropriate for everyone.

Quick self-check

Do you have a confirmed diagnosis of CLL?
Are you 18 years old or older?
Can you comfortably walk on a treadmill or use a cycling machine?
Have you checked that you don't have serious heart problems or severe bone/muscle issues stopping you from exercising?
Are you not currently receiving high-dose steroid treatment?
Do you not have uncontrolled diabetes or very high blood pressure?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, during the 12-week main period, you will be in one of three groups: an exercise-only group, an exercise and diet guidance group, or a group that does not exercise for the study. If you're in an exercise group, the sessions will be supervised or semi-supervised. We will ask you to visit for assessments at the very beginning of the study, and again after 12 weeks. These visits will involve providing fasting blood samples to check your CLL cell counts, immune system markers, and other health indicators. You'll also complete some physical fitness tests at these times to see how strong and fit you are.

After the main 12-week programme, we'll ask you to come back for one final visit 12 weeks later. This is to see if any positive changes from the exercise and diet programmes have lasted over time. The study does not involve new medication. The total time commitment for the study, including follow-up, will be around 24 weeks.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as improvements in your physical fitness, immune system, and overall well-being, particularly if you are in one of the active exercise groups. You will also be contributing valuable information to help others with CLL in the future. As with any exercise, there's a small risk of muscle soreness or minor injury, but the exercises will be supervised and carefully chosen for safety. Blood tests involve brief discomfort and a very small risk of bruising or infection. Taking part in any research study is always voluntary, and you are free to withdraw at any time without giving a reason, and this will not affect your future medical care.

Locations (1)

University of Surrey
Guildford, United Kingdom· Recruiting

Common questions

What is Chronic Lymphocytic Leukaemia (CLL)?

CLL is a type of cancer that affects white blood cells, specifically lymphocytes, which are an important part of your immune system.

Will I have to pay to take part?

No, you will not have to pay to take part in this research study.

What does 'randomised' mean in this study?

Randomised means that you will be put into one of the study groups by chance, like flipping a coin. This helps make the study fair and scientific.

Do I have to change my current CLL treatment?

No, this study is looking at lifestyle changes, not at altering your current medical treatment for CLL. You should continue with your prescribed treatments as normal.

How long will I be involved in the study?

You will be actively involved for 12 weeks, with a final follow-up visit another 12 weeks later, making the total involvement roughly 24 weeks.

How to find out more

David Bartlett, PhD

d.bartlett@surrey.ac.uk 01483 683 245 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.