A trial of aspirin to reduce the risk of cancer in people with primary sclerosing cholangitis (Asp-PSC)

Cancer type:

Bile duct cancer
Biliary tree cancers
Bowel (colorectal) cancer
Gallbladder cancer
Liver cancer

Status:

Open

Phase:

Phase 3

This trial is looking at aspirin to reduce the risk of cancer, liver disease and the need for a liver transplant.

It is for people with both:

  • primary sclerosing cholangitis
  • inflammatory bowel disease (IBD)

Cancer Research UK supports this trial.

More about this trial

Primary sclerosing cholangitis (PSC) is a long term condition where the bile ducts Open a glossary item inside and outside the liver get smaller because of inflammation and scarring.

Bile is a fluid that helps to digest food by breaking down fat. The scarring means the bile doesn’t flow properly and can cause problems.

Many people with PSC also have Crohn’s disease or ulcerative colitis which are types of inflammatory bowel disease (IBD). IBD happens when your immune system Open a glossary item attacks your bowel.

Some people with PSC develop liver failure and need a liver transplant. This means removing the liver and replacing it with a healthy liver from a donor. It’s a big operation and having a transplant has risks.

We also know from research that people with both PSC and IBD have an increased risk of cancer of the:

Everyone with both PSC and IBD can have a colonoscopy each year to look for signs of bowel cancer. But it is more difficult to look for early signs of liver, bile duct or gallbladder cancer.

Researchers would like to try and reduce the risk of people with these conditions from developing cancer or needing a liver transplant. They think taking low dose aspirin every day might help but they do not know for sure. They are doing this trial to try and find out.

Aspirin is a common painkiller Open a glossary item which is also used to reduce the risk of having a heart attack or stroke Open a glossary item. We know from previous research that aspirin might lower the risk of getting some cancers. It may also prevent some cancers from spreading, or people dying from it. But we need more research to be sure.

The main aims of this trial are to:

  • see if aspirin reduces the risk of cancer, liver problems and the need for a liver transplant in people with PSC and IBD
  • see if aspirin helps people live longer with PSC and IBD
  • see if the treatment is safe
  • learn more about the side effects of treatment
  • to find out more about the quality of life of people taking part

Who can enter

The following bullet points are a summary of 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:

  • have large duct primary sclerosing cholangitis (PSC) that was diagnosed with a ERCP test or MRCP test
  • have had a diagnosis of PSC for at least a year
  • have inflammatory bowel disease (IBD) - including Crohn’s disease, ulcerative colitis or inflammatory bowel disease unclassified
  • have been taking the same dose of ursodeoxycholic acid for at least 3 months before having tests to take part in the trial. Your dose must be under a certain amount. Your doctor will know this. You can still take part in the trial if you are not taking ursodeoxycholic acid.
  • have had a colonoscopy in the year before randomisation Open a glossary item. Or you are willing to have a colonoscopy before you join the trial.
  • have had a scan Open a glossary item of the liver, bile ducts and gallbladder within 6 months of having tests to join the trial if you have scarring of the liver (cirrhosis Open a glossary item). Or you have had a scan within 12 months if you don’t have cirrhosis. You must be willing to have a scan before you join the trial if you haven’t had one during this timeframe.
  • are aged 18 or over

Who can’t take part

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

  • have had cancer in the last 5 years. You might be able to take part if you have had non melanoma skin cancer Open a glossary item which has been treated or removed.
  • have had cancer of the bowel, bile duct or gallbladder before
  • have an inherited cancer syndrome in your family or you have a gene Open a glossary item change that increases your risk Open a glossary item of developing cancer

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

  • have another illness which could be the cause of the narrowing of your bile ducts (sclerosing cholangitis)
  • have certain types of liver disorders Open a glossary item. You doctor will know which ones.
  • have Wilson disease, which causes copper levels to build up in parts of the body including the liver and eyes
  • have cystic fibrosis
  • have an autoimmune condition Open a glossary item called IgG4 related disease
  • have had a liver transplant Open a glossary item or you are on the liver transplant waiting list. Or you have had tests to see if you are suitable for a liver transplant.
  • have had an operation to remove some or all of your bowel. This includes if you have had a stoma Open a glossary item closed.
  • have had bleeding from the food pipe (oesophagus), stomach or first part of the small intestine (duodenum) not caused by enlarged veins in the last year
  • have, or have had, heart failure
  • have glucose - 6 -phosphate dehydrogenase. Your doctor will know more.
  • have significant liver scarring from previous damage (cirrhosis). This is Childs Pugh B or C cirrhosis.
  • have higher than normal, or lower than normal, levels of thyroid Open a glossary item hormones
  • have had asthma and small growths inside the nose (nasal polyps) which doctors think have been caused by either non steroidal anti inflammatory drugs Open a glossary item (NSAIDs) or aspirin
  • have haemophilia or another illness that affects bleeding meaning you are not able to take aspirin
  • have a stomach ulcer, or you’ve had one in the past that has come back
  • have gout, which means your joints might be swollen and sore
  • have serious kidney problems
  • have been taking NSAIDs in the 4 weeks before having tests to see if you’re able to join this trial
  • are taking any other medication which helps to prevent blood clots
  • are taking methotrexate above a certain dose
  • are taking a type of antidepressant medication called selective serotonin reuptake inhibitors (SSRIs)

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

  • have had a chickenpox vaccination Open a glossary item in the 6 weeks before having tests to see if you’re able to join the trial
  • are allergic to aspirin
  • drink more than the recommended amount of alcohol. The Department of Health says this is 14 units of alcohol a week.
  • have taken part in another treatment clinical trial in the 6 weeks before starting treatment on this trial
  • are already taking aspirin

Trial design

This is a phase 3 trial. The researchers need around 968 people from the UK to take part.

It is a randomised trial. You are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

Your doctor will be able to find out which treatment you are taking if they need to.

You have either:

  • low dose aspirin
  • dummy drug (placebo Open a glossary item)

Out of every 3 people who join the trial 2 people go into the group that takes a low dose of aspirin and 1 person will go into the group that takes the dummy drug. 
 

Both aspirin and the dummy drug are tablets you take once a day with water and food. You take them for 5 years.

Samples for research
The researchers ask for extra blood and urine samples ideally at the same time as your routine tests. They would like to use the samples to find out more about PSC in the future.

You don’t have to give these samples if you don’t want to. You can still take part in the trial.

Pregnancy and breastfeeding
You can take part in this trial if you are pregnant or breastfeeding. The trial team would like to get more information about you and your pregnancy if you become pregnant while taking part. 

Questionnaires
You fill in paper questionnaires as part of the trial. This is to see how PSC and the trial treatment affect your everyday life. These are called quality of life questionnaires.

You fill them in:

  • before treatment
  • every 6 months during treatment
  • at the end of treatment

Hospital visits

You see the doctor and have some tests before taking part in the trial. This can involve more than one trip to the hospital. Tests include:

  • a physical examination Open a glossary item
  • an examination of your skin and tummy (abdomen)
  • blood tests

Other tests you might have include:

  • a colonoscopy if you haven’t had one in the past year
  • a type of ultrasound scan of your liver called a fibroscan to look for inflammation
  • your regular PSC scans Open a glossary item if you haven’t had them recently

You have a hospital visit when you start your trial treatment. The team will give you enough medication to last for 3 months and your patient diary. They will ask you to write in your diary how you feel, any side effects or symptoms and when you’ve taken your treatment. You fill in your diary throughout treatment.

The trial team call you a month after you start treatment. This is to see how you’re getting on. If you’re very unwell they might ask you to go to the hospital.

You see the trial team at the hospital every 6 months for 5 years. This is usually at the same time you would see your treatment team as part of your routine care. You have some tests at these visits. These include:

  • a physical examination
  • an examination of your skin and tummy (abdomen)
  • blood tests

Every year while on treatment you collect a poo sample. The trial team use this to look for inflammation Open a glossary item in your bowel.

The trial team also make sure you’re up to date with your scans, poo samples and colonoscopies for your PSC. You get more medication to take home at these 6 monthly visits.

End of treatment
You have a hospital visit after you’ve taken your last aspirin tablet. You have some of the same tests you had before and during treatment. 

Follow up
The trial team would like to use your medical notes to see how you are getting on for up to 5 years after you’ve finished treatment on the trial.

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 

The possible side effects of aspirin include:

  • tummy pain
  • skin rashes
  • increased bleeding
  • an increased risk of asthma if you have small, harmless growths inside your nose (nasal polyps)
  • heavier periods
  • mild kidney damage
  • swelling from being unable to get rid of fluid in the body (oedema)

There is an increased risk of having bleeding from your tummy (stomach) or bowel. And getting a stomach ulcer. Both of these side effects are rare.

We have more information about aspirin and cancer.

Location

London
Norwich

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

Professor Shahid Khan and Dr Simon Rushbrook

Supported by

Cancer Research UK
Imperial College London

Other information

This is Cancer Research UK trial number CRUK/22/010

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

19804

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

Last reviewed:

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