AuthorisedTherapeutic confirmatory (Phase III)Interventional

COLchicine to mitigate accelerated Atherosclerosis induced by immune checkpoint inhibitors in patients with cancer: the COLA trial

This study, called COLA, is for cancer patients who are taking special immune treatments. Sometimes, these treatments can cause inflammation in the body, which might affect the heart and blood vessels, leading to a condition called atherosclerosis. Atherosclerosis is when arteries harden and narrow. We are testing if a common anti-inflammatory medicine called colchicine can help prevent or reduce this problem. We will use special scans to look at changes in the blood vessels around the heart over 12 weeks. The study aims to find out if colchicine can keep your heart and blood vessels healthier while you're receiving your cancer treatment.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Amsterdam UMC Stichting

Enrolment target

Start

31 Mar 2025

Atherosclerosis Cancer

What is this study about?

When people are treated for cancer with certain types of immune-boosting drugs (called immune checkpoint inhibitors), it can sometimes cause unintended inflammation in the body. While these treatments are very good at fighting cancer, this inflammation can, in some cases, lead to problems with the heart and blood vessels – specifically, a condition called atherosclerosis. This is when your arteries can get stiff and narrow, which could potentially cause heart issues down the line.

This study, named the COLA trial, is investigating a medicine called colchicine. Colchicine is an older, well-known drug often used for conditions like gout, and it's known for its anti-inflammatory effects. The main idea is to see if taking colchicine alongside your cancer treatment can help reduce or prevent this inflammation in your blood vessels, thereby protecting your heart.

Researchers will be using special scans to look very closely at the blood vessels around your heart and in other parts of your body, like your neck. By taking these scans at the beginning and again after 12 weeks, they can compare and see if there are any changes in the inflammation levels. They'll also be looking at other important health markers to get a full picture of how colchicine might be helping.

Key takeaways

This study is for cancer patients on specific immune treatments.
It tests if colchicine can protect your heart and blood vessels.
Colchicine is a common anti-inflammatory medicine.
Special scans will look at changes in your blood vessels.
The study lasts about 12 weeks for active participation.
It aims to make your cancer treatment safer for your heart.

Who may be eligible?

To be part of this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

More detailed specific requirements would need to be discussed with the study team. These might include what type of cancer you have, what specific immune treatments you are receiving, and your general health condition.

It's important to know that you wouldn't be able to join if you have certain other health issues or are taking medicines that might interact with colchicine or the study procedures. The study team will review your medical history carefully to make sure the study is safe and appropriate for you.

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?
Are you currently receiving immune checkpoint inhibitor treatment for cancer?
Are you able to have PET scans?
Are you generally in good health apart from your cancer, as determined by a study doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medication, colchicine, while continuing your regular cancer treatment. You would have two main visits for special scans: one at the very beginning of the study, and another 12 weeks later. These scans, called PET scans, are a bit like x-rays but they show how active cells are, helping us see inflammation in your blood vessels. You might also have blood tests at these visits.

During the 12 weeks of the study, the research team would regularly check in with you to see how you're feeling and to monitor for any side effects. After the 12-week scan, your active participation in the study involving colchicine and the main scans would conclude, but the team might continue to gather some health information from your medical records over a longer period to understand any long-term effects. The total active study duration for you would be around 12 weeks.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as receiving a medicine that might reduce heart and blood vessel inflammation, which could improve your long-term heart health. You would also be closely monitored by a healthcare team. However, there are also potential risks, as colchicine, like any medicine, can have side effects, such as tummy upsets. There's also the discomfort of blood tests and the radiation exposure from a PET scan, although this is carefully managed. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is atherosclerosis?

Atherosclerosis is when your arteries, which carry blood from your heart, get stiff and narrow due to a build-up of fatty materials. This can make it harder for blood to flow and can lead to heart problems.

What is colchicine?

Colchicine is an older medicine that helps reduce inflammation in the body. It's commonly used to treat conditions like gout.

What are immune checkpoint inhibitors?

These are special cancer drugs that help your body's own immune system fight cancer cells better. They are a type of immunotherapy.

Will I still get my cancer treatment?

Yes, you would continue to receive your regular cancer treatment while participating in this study.

What is a PET scan?

A PET scan is a special type of imaging test that uses a small amount of a safe, radioactive substance to show how your organs and tissues are working, helping doctors spot inflammation.