A trial of simvastatin to prevent heart and lung complications after surgery (Prevention HARP 2)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer

Oesophageal cancer

Status:

Closed

Phase:

Phase 2

This trial is using simvastatin to prevent heart and lung complications after surgery to remove cancer of the food pipe or lung cancer.

More about this trial

Doctors use surgery to remove the food pipe (oesophagus) to treat oesophageal cancer.

They also use surgery to remove cancer from the lung. You might have part of the lung removed or the whole lung.

After having surgery you might have complications. It is possible that if the complications are very severe they could lead to a heart attack or breathing problems called acute respiratory distress syndrome. This will affect how well you recover after surgery.

Simvastatin is a drug used to treat people who have a high level of fat (cholesterol) in their blood. Simvastatin can also reduce inflammation Open a glossary item .

Researchers think simvastatin could help reduce inflammation before and after surgery. And so prevent the complications of surgery.

In this trial some people will have simvastatin before and after surgery. And some will have a dummy drug (placebo Open a glossary item ).

The main aim of this trial is to find if simvastatin can prevent complications after surgery to remove the food pipe, part of a lung or a whole lung.

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial 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 trial if all of the following apply. You:

are having surgery to remove your food pipe, part of the lung or a whole lung
are able to take medication by the mouth or through a feeding tube before having your surgery
have satisfactory blood test results
are willing to use reliable contraception during the trial and for at least 30 days after treatment if there is any chance you or your partner could become pregnant
are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply. You:

have a liver disease such as cirrhosis
have kidney problems (your doctor will test for this)
are lactose intolerant
are already taking statin medication
are allergic to statins or have had a bad reaction to them
are taking medication such as fibrates to lower the fat (lipids) in your blood
are taking medication that affects CYP enzymes
have taken medication as part of another clinical trial in the past month
are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The team need 452 people to take part.

It is a randomised trial. Everyone is put into 1 of 2 groups. Neither you or 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:

simvastatin
a dummy drug (placebo )

Prevention HARP 2 trial diagram

Simvastatin and the dummy drug are tablets. You take them once a day for 4 days before your surgery. A member of the trial team will phone you to tell you when to start taking the tablets.

You have a diary to write when you take your tablet. You hand this into a member of the trial before your surgery.

While in hospital recovering from the surgery you continue to have the tablets for 7 days.

You fill in a questionnaire when you agree to take part and again 3 months after your surgery. The questions ask about how you are and any side effects. This is called a quality of life questionnaire.

You also have another questionnaire to fill in 3 months after surgery. The questions ask about any services such as community, social, hospital and care services you used after leaving hospital. This is called a resources use questionnaire.

The researchers will take blood samples before you have surgery and a week afterwards. This is to see how much simvastatin is in your blood. These samples are taken as part of your routine blood tests.

Hospital visits

You see the doctor to have some tests before taking part. These tests include:

a physical examination
blood tests
urine test

A member of the trial team will phone you to tell you when to start taking your tablets. They phone again before you go into hospital and ask if you have had any side effects from taking the tablets.

On the day of surgery you see the doctor again for:

a physical examination
blood tests
a breathing test to find out how much air you normally breathe in (tidal volume)
heart trace (ECG )

After surgery your doctor will talk to you about your follow up.

Side effects

Simvastatin is a safe drug. It has been used to treat people with high cholesterol with few side effects. Any side effects go away when simvastatin is stopped.

Side effects include:

a change in the way your liver works
muscle pain, tenderness or weakness

The side effects of simvastatin are more common in people who drink grapefruit juice. So you should not drink grapefruit juice during the time you are in the trial.

Your doctor will talk to you about the side effects of simvastatin before you agree to take part.

Recruitment start:

22/11/2016

Recruitment end:

22/09/2022

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.

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Questions to ask your doctor about clinical trials

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

Chief Investigator

Dr Murali Shyamsundar

Supported by

Belfast Health & Social Care Trust
National Institute for Health Research (NIHR)

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Email

Last review date

31 January 2023

CRUK internal database number:

14472