RecruitingOBSERVATIONAL

IMMUNO-FIT Observational Study

This study, called IMMUNO-FIT, aims to understand how immunotherapy for solid cancers affects patients' physical fitness, quality of life, and any side effects they experience. We know immunotherapy can cause various side effects, and we want to see if your fitness level plays a role in how well you manage them and how your body responds to treatment. Participants will have fitness tests and complete questionnaires before starting immunotherapy and again after 12 weeks. We'll also collect blood samples and follow up on your health for up to two years. Your cancer treatment will remain exactly as your doctor planned. This research will help us learn how to better support patients undergoing immunotherapy in the future.

At a glance

Status

Recruiting

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

Start

26 Mar 2026

Estimated completion

31 Dec 2028

Neoplasms Immunotherapy Physical Fitness Quality of Life Drug-Related Side Effects and Adverse Reactions

What is this study about?

When you have immunotherapy for cancer, your doctors want to give you the best chance of fighting the disease while keeping you as well as possible. This study aims to understand certain aspects of this journey. We want to see how this treatment affects your physical fitness and your overall quality of life, meaning how you feel day-to-day. Immunotherapy can sometimes cause side effects that might make daily activities harder or even lead to treatment adjustments. We're interested in whether your fitness level influences how well you tolerate these side effects and whether being fitter helps you cope better with treatment.

At the moment, we don't fully understand how someone's fitness changes during immunotherapy or if your fitness before treatment affects long-term results. By observing people like you who are undergoing immunotherapy, we hope to gain valuable insights. This information could eventually help us find ways to support patients better, perhaps by designing specific exercise programmes to help them stay fit and feel better during and after their cancer treatment.

Importantly, this is an 'observational study,' which means we will simply be watching and learning. Your cancer treatment will not be changed or influenced by this study; you will receive the standard treatment your doctors recommend, exactly as planned. We are just collecting information to learn more.

Key takeaways

The study explores how cancer immunotherapy affects your fitness and well-being.
It's an 'observational study', meaning your cancer treatment remains unchanged.
Participation involves fitness tests, questionnaires, and blood samples at the start and after 12 weeks.
The goal is to help improve support for future patients receiving immunotherapy.
You participate for up to 2 years, with key assessments in the first 12 weeks.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for adults aged 18 or over. You'd be eligible if you have a solid cancer (meaning not a blood cancer) and are about to start a type of immunotherapy called an immune checkpoint inhibitor. This applies whether your treatment is to prevent cancer from returning (adjuvant) or to treat cancer that has spread (metastatic/palliative).

Key things we'd check for include your ability to do a special fitness test that involves exercise, and if you haven't recently had another type of immunotherapy that might confuse the results. We also need to make sure you're well enough to take part and can understand and agree to the study procedures.

There are certain health conditions that would prevent you from joining, mainly related to severe heart or lung problems that would make the fitness test unsafe. If you've previously had immunotherapy, there are specific timeframes that would need to be met. The research team will carefully review all your medical information to confirm if you can safely participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a solid tumour (not a blood cancer)?
Are you about to start a new immunotherapy treatment?
Are you generally well enough to do an exercise bike or treadmill test?
Have you not had certain other immunotherapies recently (the team will check details)?
Do you understand what taking part would involve and are you happy to agree?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your involvement will span up to two years, with specific assessments at the beginning and after 12 weeks. Before you start your immunotherapy, you will undergo a special fitness test called cardiopulmonary exercise testing (CPET). This involves exercising on a bike or treadmill while we monitor your heart and breathing. You'll also fill out questionnaires about your quality of life. We'll take some blood samples at this initial visit.

After 12 weeks of immunotherapy, you'll repeat the fitness test, questionnaires, and blood tests. Throughout the study, we will also collect information on how your cancer is progressing and your quality of life from your routine medical records for up to 24 months. Remember, this is an observational study, so you won't be given any extra medication or treatments by the study team – your cancer treatment will continue as planned by your doctors. A small number of participants might also be asked if they'd like to have an optional extra biopsy at 12 weeks, but this is entirely your choice.

Potential risks and benefits

Taking part in this study may not directly benefit you, as it's observational and won't change your planned cancer treatment. However, the information gathered will be very valuable in helping future patients by improving our understanding of how immunotherapy affects fitness and quality of life. Potential risks are generally low, mainly related to the fitness test, which is carefully supervised and similar to a stress test you might have in a hospital. Blood tests carry a small risk of bruising. For those choosing to have an optional research biopsy, there are standard risks associated with that procedure, which would be fully explained. You are in control and can withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital Southampton NHS Foundation Trust
Verified postcode
Southampton, United Kingdom· Recruiting

Common questions

What is immunotherapy?

Immunotherapy is a type of cancer treatment that helps your own immune system find and fight cancer cells.

What is an 'observational study'?

It means we're watching and learning from what happens naturally. We're not giving any new medicines or changing your existing treatment plan.

Will my doctors know I'm in the study?

Yes, your cancer care team will be aware of your participation and will continue to provide your standard medical care.

What does the fitness test involve?

It's an exercise test, usually on a bike or treadmill, where we monitor your heart and breathing to understand your physical fitness level.

Can I stop participating if I change my mind?

Absolutely. You can withdraw from the study at any time without having to give a reason, and it won't affect your medical care.

How to find out more

Kashuf Khan, MBBS, MRCS

k.a.khan@soton.ac.uk +442381204308 Official trial record

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