RecruitingOBSERVATIONAL

Cardiopulmonary Toxicity of Thoracic Radiotherapy

This study is investigating how radiotherapy for lung or oesophageal cancer might affect your heart and lungs. While radiotherapy is important for treating cancer, it can sometimes cause side effects in nearby healthy tissues. There's growing evidence that radiotherapy might lead to a condition called pulmonary hypertension (PH), which affects the blood vessels in the lungs and can be serious. We aim to understand if PH is a regular side effect of radiotherapy in these patients. By studying this, we hope to find ways to make radiotherapy safer and improve the long-term health and quality of life for people with lung and oesophageal cancer.

At a glance

Status

Recruiting

Sponsor

University Medical Center Groningen

Enrolment target

320

Start

01 Sep 2018

Estimated completion

01 Apr 2027

Oesophageal Cancer Non Small Cell Lung Cancer

What is this study about?

When you have radiotherapy for lung or oesophageal cancer, it’s very good at treating the cancer in that area and can help you live longer. However, because your heart and lungs are close by, they can also be affected by the radiation. Sometimes, this can lead to side effects. Experts are starting to think that the radiation might cause problems with your heart and lungs that aren't always recognised.

One specific area of concern is a condition called pulmonary hypertension (PH). This is when the blood pressure in the arteries leading to your lungs becomes too high. This can make your heart work harder and can affect your overall health. We already know that PH can be serious, but it's not yet clear if radiotherapy commonly causes it in people treated for lung or oesophageal cancer.

This study aims to find out if PH is indeed a common side effect after radiotherapy for these cancers. By using tests like heart scans (echocardiography and MRI) and blood tests, we want to see how radiation affects the heart and lungs over time. We also want to understand what factors, like the exact dose of radiation, might increase the risk of PH. If we confirm that radiotherapy can cause PH, this information will be vital. It will help doctors adjust treatments to reduce this risk in the future and find better ways to support patients, aiming to improve their quality of life after cancer treatment.

Key takeaways

The study investigates if radiotherapy for lung/oesophageal cancer can cause pulmonary hypertension.
It aims to make radiotherapy safer and improve patients' long-term health.
Participation involves extra heart scans and blood tests.
The findings could lead to better ways to protect the heart and lungs during cancer treatment.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is for adults aged 18 or over who have been diagnosed with certain types of oesophageal cancer (in the middle or lower part of the food pipe) or lung cancer (non-small cell lung cancer stages IIA-III, or stage IV with specific brain metastases; or limited small cell lung cancer stages I-IIIB). You need to be planning to have radiotherapy that aims to cure your cancer.

To be eligible, you should also be generally well enough to manage your daily activities, with a WHO score of 0-2 (meaning you're fully active or limited only in strenuous activity). You also need to be willing to give written permission to take part.

There are some reasons you might not be able to join, such as having had recent heart failure or a blood clot in your lungs within the last two months. If you have very severe COPD (a lung condition called 'gold IV'), a BMI over 35, or have had radiotherapy to your chest before, you wouldn't be able to take part. Also, if you have any conditions that would prevent you from having an MRI scan, you wouldn't be able to join the MRI part of the study.

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 oesophageal cancer (mid/lower) or specific stages of lung cancer?
Are you planned for radiotherapy to cure your cancer?
Have you had heart failure or a lung blood clot in the last 2 months? (If yes, you may not be eligible)
Do you have very severe COPD (gold IV) or a BMI over 35? (If yes, you may not be eligible)
Are you able to have an MRI scan?

Answer every question to see your result.

What does participation involve?

The study aims to understand how your heart and lungs react to radiotherapy. If you join, you would likely have additional tests beyond your standard cancer treatment. This might include heart scans (echocardiography and MRI) and blood tests at different times after your radiotherapy. These tests will help the researchers see how your heart and lungs are working and track any changes. The specific number of visits and the full duration of follow-up would be explained to you in detail.

Potential risks and benefits

Participating in this study might help us understand more about how radiotherapy affects the heart and lungs, potentially leading to safer treatments for future patients. There are no direct personal benefits for you within the study beyond the information gained from the extra tests. The study procedures, such as blood tests or MRI scans, carry very low risks, similar to routine medical procedures. The main benefit is contributing to knowledge that could help others. Remember, you can choose to leave the study at any time without affecting your medical care.

Locations (3)

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

Universitaire Ziekenhuizen Leuven
Verified postcode
Leuven, Belgium· Terminated
Radboud UMC
Verified postcode
Nijmegen, Netherlands· Recruiting
NHS Greater Glasgow and Clyde
Verified postcode
Glasgow, United Kingdom· Terminated

Common questions

What is pulmonary hypertension?

It's a condition where the blood pressure in the arteries leading to your lungs becomes too high, making your heart work harder.

Why is this study important for people with cancer?

It aims to understand if radiotherapy causes this heart and lung condition, so doctors can make treatment safer and improve long-term health.

Will I receive any new medication in this study?

No, this study is observational; it focuses on understanding side effects, not providing new treatments.

How long will I be in the study?

This will be fully explained, but it involves monitoring your health for a period after your radiotherapy treatment starts.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your ongoing medical care.

How to find out more

CT Muijs, MD PhD

c.t.muijs@umcg.nl 00315036115179 Official trial record

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