RecruitingNAINTERVENTIONAL

REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs

This study is investigating a technique called Remote Ischaemic PreConditioning (RIPC) in people with lymphoma who are having anthracycline chemotherapy. Anthracyclines are powerful cancer drugs but can sometimes affect the heart. RIPC involves briefly cutting off and restoring blood flow to an arm or leg, like using a blood pressure cuff. The aim is to see if this simple process can help protect the heart from potential side effects of the chemotherapy. Researchers want to know if RIPC is safe and effective in preventing heart problems. This is a multinational study where some patients will receive RIPC and others a 'dummy' version, without knowing which one they are getting.

At a glance

Status

Recruiting

Phase

Sponsor

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Enrolment target

608

Start

18 Jan 2022

Estimated completion

01 Dec 2026

Anthracycline-induced Cardiac Toxicity Lymphoma

What is this study about?

When you have lymphoma, a type of cancer, doctors often use strong medicines called anthracyclines as part of your chemotherapy. These medicines are very good at fighting cancer, but sometimes they can unfortunately affect the heart. This study is designed to look into a way to help protect your heart from these potential side effects.

The method being tested is called Remote Ischaemic PreConditioning (RIPC). It's a simple, non-invasive technique that involves briefly squeezing and then releasing a blood pressure cuff on your arm or leg a few times. Think of it like a gentle workout for your blood vessels. The idea is that these short moments of reduced and restored blood flow might 'pre-condition' your body, making your heart more resilient to the effects of the chemotherapy.

This study is important because if RIPC works, it could offer a safe and easy way to help people with lymphoma receive their essential cancer treatment with less worry about their heart health. Researchers will carefully compare heart health in patients who receive RIPC with those who receive a 'sham' (dummy) version of the treatment, so they can truly understand its effects.

Key takeaways

This study tries to protect your heart during lymphoma chemotherapy.
It uses a simple, blood pressure cuff technique called RIPC.
It's a comparison study; some will get RIPC, others a dummy treatment.
Your heart will be carefully monitored with scans and blood tests.
Participation means extra tests, but aims to find safer treatments.
You can stop participating at any time.

Who may be eligible?

You might be able to take part in this study if you are 18 years or older and have certain types of lymphoma, or if you have breast cancer. You must be scheduled to have chemotherapy that includes anthracycline medicines, and your doctor expects you to have at least five cycles of this treatment. Before starting, your heart function needs to be generally good, as measured by a heart scan.

To be included, you also need to have at least one risk factor for potential heart problems from this type of chemotherapy. This could be things like having had previous heart issues (but not heart failure), being over 65, having high blood pressure, kidney disease, being a current or past smoker, or having a higher body weight. Your doctor will check all these carefully.

However, you won't be able to join if you've already had anthracycline chemotherapy for cancer before, or if you have certain existing serious heart conditions like heart failure or certain heart rhythm problems. You also can't take part if you have medical devices that aren't safe for MRI scans, or if you are already in another clinical trial.

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 or older?
Do you have certain types of lymphoma or breast cancer?
Are you about to start anthracycline chemotherapy for at least 5 cycles?
Do you have generally good heart function right now?
Do you have any heart-related risk factors (like high blood pressure or being over 65)?
Have you not had anthracycline chemotherapy before?

Answer every question to see your result.

What does participation involve?

If you join this study, it will be over a few years, but with a lot of the main tests happening during your chemotherapy and up to about nine weeks after it finishes.

Before you start chemotherapy, you will have a detailed heart scan (called a Cardiac MRI) and blood tests to check your heart health. If your heart function is suitable, you'll be randomly assigned to either receive the RIPC treatment or a 'sham' (dummy) treatment – like a blood pressure cuff on your arm that doesn't actually squeeze. Neither you nor your doctors will know which group you are in.

You will continue with your regular chemotherapy. During this time, you will have more blood tests after your third and last chemotherapy cycles. A final heart scan and blood tests will be done about nine weeks after your last chemotherapy session. After that, doctors will keep in touch with you at regular intervals (6, 12, 18, 30, and 42 months) to see how you are doing, until the study concludes.

Potential risks and benefits

The potential benefits of taking part could include the close monitoring of your heart health throughout your chemotherapy. Plus, if RIPC is effective, it might help protect your heart from side effects of anthracycline chemotherapy. The risks associated with RIPC itself are generally low; it's similar to having your blood pressure taken. Potential risks of the study include the additional blood tests and MRI scans, which can be time-consuming or uncomfortable for some. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (24)

Aarhus University
Verified postcode
Aarhus, Denmark· Recruiting
Hospital Jaques Monod, El Havre
Verified postcode
Montivilliers, France· Not yet recruiting
Henri Becquerel
Verified postcode
Rouen, France· Recruiting
University Hospital Duesseldorf UDUS
Verified postcode
Düsseldorf, Germany· Recruiting
Amsterdam UMC
Verified postcode
Amsterdam, Netherlands· Not yet recruiting
Hospital da Luz Learning Health (GLSMED)
Verified postcode
Lisbon, Portugal· Recruiting
IPO Lisboa
Verified postcode
Lisbon, Portugal· Recruiting
Hospital Universitario Príncipe de Asturias
Verified postcode
Alcalá de Henares, Spain· Not yet recruiting
Centro Medico Teknon
Verified postcode
Barcelona, Spain· Recruiting
Instituto Catalán de Oncología
Verified postcode
Barcelona, Spain· Recruiting
Hospital Universitario Virgen de las Nieves
Verified postcode
Granada, Spain· Recruiting
Centro Nacional de Investigaciones Cardiovasculares (CNIC)
Verified postcode
Madrid, Spain· Recruiting

Common questions

What is Remote Ischaemic PreConditioning (RIPC)?

It's a simple technique using a blood pressure cuff on your arm or leg to briefly squeeze and release, which might help protect your heart.

Why is this study being done?

To see if RIPC can safely reduce the risk of heart problems for lymphoma patients receiving certain chemotherapy drugs.

Will I know if I'm getting the real RIPC or the dummy treatment?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know which treatment you are receiving.

What kind of tests will I have?

You'll have heart scans (MRIs) and blood tests at different points before, during, and after your chemotherapy.

How long will I be followed up in this study?

After your main tests, you'll have check-ups for several years, potentially up to 42 months (3.5 years).

How to find out more

Borja Ibañez, MD PhD FESC

bibanez@cnic.es 914501200 Official trial record

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