A study to find out if a simple technique can stop heart damage caused by some chemotherapy drugs (ERIC-ONC)

Cancer type:

All cancer types

Status:

Open

Phase:

Other

This study is looking at whether a technique that restricts blood to the upper arm for short periods can stop heart damage caused by some chemotherapy drugs.

More about this trial

Chemotherapy Open a glossary item is a usual treatment for cancer. And anthracyclines Open a glossary item are one of the common types of drug that you might have. These include drugs such as epirubicin and doxorubicin.

All drugs have side effects. One of the side effects of anthracycline drugs is damage to the heart. At the moment, there isn’t a treatment to stop heart damage caused by these drugs. So, researchers are looking for ways to protect the heart. 

In this study, they are looking at a technique called remote ischaemic conditioning or RIC. It involves inflating and deflating a blood pressure cuff on your upper arm before having chemotherapy. This safely restricts the blood supply for a short time.

Early research in the laboratory shows that RIC helps protects the heart, lungs and kidneys during a heart attack or surgery. Anthracycline chemotherapy can damage the heart muscle in a similar way to a heart attack. So, researchers think RIC might help.  But they aren’t sure so want to find out more. 

Some people in the study will have the RIC technique. And some will have a dummy technique. 

The aim of the study is to find out if RIC protects the heart from damage that anthracycline chemotherapy can cause. 

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 
 
Who can take part
You may be able to join this study if all of the following apply. 
You:
  • are having chemotherapy that includes an anthracycline drug such a doxorubicin or epirubicin
  • can tolerate having a blood pressure arm cuff inflated on your arm
  • are 16 to 80 years old 
Who can’t take part
You cannot join this study if any of these apply. 
You:
  • have problems with your heart such as a heart attack, chronic disease of the heart muscle, a rare heart condition called Fabry Disease or a build up of a protein called amyloid in your heart
  • have narrowing of the arteries around your heart or brain (peripheral vascular disease)
  • have a problem with how your kidneys work
  • have diabetes and are taking a type of drug called sulphonylureas such as glipizide or glyburide
  • have had the lymph nodes Open a glossary item removed under one arm and for some reason you can’t have the blood pressure cuff inflated on your other arm  

Trial design

This study is for people having their treatment at University College Hospital, London. The researchers hope about 128 people will take part. 
 
It is a randomised study. You are put into 1 of 2 groups by a computer. Neither you nor your doctor can choose which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
 
You have 1 of the following:
  • the RIC technique
  • a dummy technique (placebo Open a glossary item

The researcher puts a blood pressure cuff on your right upper arm. It is inflated for 5 minutes and then deflated for 5 minutes. This is repeated 4 times before having chemotherapy. 
 
In the RIC group the cuff is fully inflated to restrict blood flow for a short period. In the dummy technique group the cuff is not as inflated as much so it doesn’t restrict blood flow. 
 
It takes about 40 minutes. You then have your chemotherapy as planned. This will take between 30 minutes and 2 hours depending on which treatment you are having.
 
Echocardiogram 
The researchers are assessing the effect of chemotherapy on the heart and the potential benefit of RIC using various methods. Firstly, they assess heart function using an ultrasound scan (echocardiogram Open a glossary item). Blood tests, before and after treatment, measure substances that the injured heart releases. The researchers will compare the results before treatment and after chemotherapy. This will detect the changes in the heart and any protection that RIC gives.
 
MRI scan
You will also have an MRI scan Open a glossary item of your heart before and after treatment. This is a quick scan and takes about 10 minutes. Researchers will compare this newer way of checking heart function with the usual echocardiogram test. Some people might have a problem with being in an enclosed space. This is called claustrophobia.  You don't have to have the MRI scan if you don't want to. You can still take part in the trial. 
 
Chemotherapy
You have your chemotherapy every few weeks. Each period is called a cycle of treatment. Between your 5th and 6th cycle of chemotherapy you have a miniature,  patch ECG heart monitor fitted. You wear this for 2 weeks. It does not interfere with normal activity or bathing. The device is posted back, so you do not need to return for another hospital visit. 
 
Samples for research
You have extra blood and urine tests as part of this study. The researchers will use the samples to look at:
 
your genes Open a glossary item
biomarkers Open a glossary item 
 

Hospital visits

You see a doctor before you join the study. They will discuss the study with you and you have some tests. These include:

  • heart trace (ECG) Open a glossary item
  • heart scan (echocardiogram) Open a glossary item
  • MRI scan of your heart

You give some blood and urine samples before starting chemotherapy.

You see the study team when you finish chemotherapy for a check up at:

  • 1 month
  • 3 months
  • 6 months
  • 1 year

At each visit you might have blood tests, urine tests and a heart scan.

The researchers will contact you 5 years after you finish chemotherapy to see how you are getting on.

Side effects

The researchers know from previous studies that the RIC technique is safe. When the cuff is inflated you may feel pins and needles in your hand but this is not harmful. Some people:
  • find the cuff inflation uncomfortable
  • develop very mild bruising of the skin on the upper arm

There is a very small possibility that having an MRI scan can make you feel uneasy if you have problems being in enclosed spaces. 

Location

London

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr J Malcolm Walker
Professor Derek Yellon

Supported by

NIHR Biomedical Research Centres (BRCs) Award
University College London (UCL)
University College Hospital Special Charity Trustees (McLean/Greenbaum Legacy)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14982

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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