Active not recruitingOBSERVATIONAL

BIOMARKER and IMAGING CHARACTERISATION of INFLAMMATORY ATHEROMA in PATIENTS RECEIVING IMMUNOTHERAPY and ANGIOGENESIS INHIBITORS

New cancer treatments like immunotherapies (ICIs) and anti-angiogenesis drugs (VEGF inhibitors) are very good at fighting cancer. However, it's becoming clear that they can sometimes cause side effects, including problems with the heart and blood vessels, like a higher risk of heart attack or stroke. We don't fully understand why these side effects happen. This study aims to use special scans and tests to see how these cancer drugs, used alone or together, affect your blood vessels and heart. We also want to understand changes in blood markers. The goal is to learn more so we can help patients stay healthier while getting effective cancer treatment.

At a glance

Status

Active not recruiting

Sponsor

NHS Greater Glasgow and Clyde

Enrolment target

Start

30 Aug 2022

Estimated completion

20 Nov 2024

Cancer Cardiotoxicity Atherosclerotic Disease

What is this study about?

You might be aware that new medicines called immunotherapies (like ICIs) and anti-angiogenesis drugs (like VEGF inhibitors) have changed how we treat many types of cancer, including melanoma, kidney, liver, and lung cancer. These treatments can be very effective, sometimes making cancer vanish.

However, doctors have started to notice that these powerful drugs can sometimes have unwanted effects on the heart and blood vessels. Patients might experience things like high blood pressure, a weaker heart, or even an increased risk of heart attack or stroke. These side effects can be serious and, in some cases, might even mean pausing or stopping crucial cancer treatment. We don't fully understand why these problems happen, and that's what this study wants to find out.

The main goal of this study is to look closely at how these cancer drugs affect your blood vessels, particularly looking for any inflammation, and how they impact your heart function. We'll also examine changes in certain chemicals in your blood. This research is observational, which means we will be watching and learning without changing your cancer treatment plan. We hope that by understanding these effects better, we can help patients avoid or manage potential heart and blood vessel problems in the future, allowing them to continue their life-saving cancer treatment safely.

Key takeaways

New cancer drugs can sometimes affect the heart and blood vessels.
This study wants to understand why these side effects happen.
It uses special scans and blood tests to learn more.
Your cancer treatment will not be changed by taking part.
You'll have two sets of appointments over about six months.
Your contribution helps improve future patient care.

Who may be eligible?

To join this study, you need to be an adult (18 years old or older) who has been diagnosed with cancer. Importantly, your doctors must have already decided that you will be starting treatment with either immunotherapy, anti-angiogenesis drugs, or a combination of both, here at the Beatson West of Scotland Oncology Centre. We also expect that you will live for at least another six months.

You cannot take part if you are unable or unwilling to give your clear permission to be in the study. Also, if you have diabetes and are taking medication for it (either pills or insulin), you would not be able to join. Finally, if you have already had treatment with either of these types of cancer drugs in the last year, you wouldn't be eligible.

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?
Have you been diagnosed with cancer and are starting immunotherapy or anti-angiogenesis drugs (or both)?
Are you *not* currently taking medication for diabetes (pills or insulin)?
Have you *not* had these specific cancer treatments in the last 12 months?
Do you feel able to give your clear permission to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your cancer treatment plan will not change; you will still receive the treatments your doctors have planned for you. You will have a special scan called a PET-CT scan before you start your cancer treatment and then again six months after starting. This scan helps us look at your blood vessels.

In addition to the scans, you will also have an ultrasound scan of your heart (called an echocardiography) and a special test of the tiny blood vessels in your fingertips using a machine called an EndoPat. We will also collect blood and urine samples from you at these time points. The total duration of your active participation will be about six months, involving two main sets of appointments.

Potential risks and benefits

By taking part, you won't directly benefit from new treatment, as this is an observational study. However, you will be helping doctors learn more about how cancer treatments affect the heart and blood vessels. This knowledge could help improve care for many patients in the future. The risks involve standard medical procedures like blood tests, which can cause minor bruising or discomfort, and PET-CT scans, which involve a small amount of radiation exposure, similar to other medical imaging. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

Beatson West of Scotland Cancer Centre
Verified postcode
Glasgow, United Kingdom

Common questions

What is an 'immunotherapy' or 'anti-angiogenesis drug'?

These are modern cancer medicines. Immunotherapies help your body's immune system fight cancer, and anti-angiogenesis drugs stop new blood vessels from feeding the cancer.

Will my cancer treatment change if I join this study?

No, your cancer treatment plan will stay exactly the same. This study is just observing what happens while you receive your planned treatment.

What is a PET-CT scan?

It's a type of scan that uses a special dye to help doctors see detailed pictures inside your body, including your blood vessels, to check for any changes or inflammation.

Why can't people with diabetes on medication join?

The study needs to make sure that any changes seen are due to the cancer drugs and not other health conditions or medications, specifically those that might affect blood vessels.

How long will I be involved in the study?

You will be involved for about six months, with appointments at the start of your treatment and then six months later.