A study looking at whether aspirin and ticagrelor affects how cancer spreads

Cancer type:

All cancer types
Bowel (colorectal) cancer
Breast cancer
Cancer spread to the brain
Cancer spread to the liver
Cancer spread to the lung
Colon cancer
Rectal cancer
Secondary cancers

Status:

Open

Phase:

Phase 1

This study is to find out what effect aspirin and ticagrelor have on how cancer spreads.

More about this trial

Cancer cells can enter the bloodstream and circulate around the body. These are called circulating cancer cells. Sometimes these cancer cells leave the bloodstream and start growing at different parts of the body (metastases).

Platelets are blood cells. They help the blood to clot when there is an injury causing bleeding. Researchers know that circulating cancer cells interact with platelets in the blood. This may help protect the cancer cells and spread them throughout the body.

Aspirin and ticagrelor block platelets. People who have had heart attacks already use both drugs. How these drugs work is well understood. Researchers want to find out if blocking platelets may affect how cancer spreads. They also want to find out how this happens.

In this study you will take both aspirin and ticagrelor by themselves. And then you take both of them together.

There are 2 parts to this study. The 1st part is open to any people with a solid tumour Open a glossary item that has spread to another part of the body. The 2nd part is open to women with breast cancer that has spread and to people with bowel cancer that has spread.

The aims of this study are

  • To find what effect ticagrelor has on the interaction between circulating cancer cells and platelets
  • To compare taking aspirin and ticagrelor together with taking each one by itself

Who can enter

The following bullet points list the entry conditions for this study. If you are unsure about any of these speak with your doctor or the study team. They will be able to advise you.

There are 2 parts to this study.

You may be able to join the 1st part if you are between 18 to 85 years old and have a solid tumour that has spread to another part of the body.

You may be able to join the 2nd part if you

  • Are a woman whose breast cancer has spread to another part of the body
  • Have bowel cancer that has spread to another part of the body

And you must

  • Have satisfactory blood test results
  • Be well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Be willing to use 2 reliable forms of contraception if there is any chance you or your partner could become pregnant
  • Be between 18 and 85 years old

You cannot join this study if any of these apply. You

  • Have had more than 3 different types of chemotherapy to treat your cancer spread
  • Are currently having chemotherapy
  • Are taking tamoxifen
  • Are taking medication that affects how the platelets work
  • Are taking medication that thins your blood for example warfarin
  • Are taking non steroidal anti inflammatory drugs Open a glossary item (NSAIDs)
  • Are taking corticosteroid tablets
  • Are taking other medication that affects body substances called CYP enzymes
  • Have had to stop taking aspirin or ticagrelor in the past because you couldn’t tolerate it
  • Have had a bleed inside the skull
  • Have an existing problem with bleeding
  • Have had a bleed in your tummy (stomach) or gut (intestines) that meant you needed a blood transfusion in the past year
  • Have had a peptic ulcer in the past year
  • Have gout
  • Have any other physical condition that the study team think would make you unsuitable to take part
  • Are pregnant or breastfeeding

You can’t join part 2 if you have had another cancer in the 5 years before you were diagnosed with breast cancer or bowel cancer apart from non melanoma skin cancer Open a glossary item or any other successfully treated cancer.

Trial design

This is a phase 1 study. There are 2 parts to the study.

In the 1st part the researchers need a 100 people to join. The team will take 5 blood samples from you over an 8 week period. They will use these samples in a laboratory study Open a glossary item to find out more about how platelets affect the processes that cancer uses to spread.

For the 2nd part the researchers need 30 women with breast cancer and 30 people with bowel cancer to join.

To begin with you will be put into 1 of 2 groups by a computer. This is called randomisation Open a glossary item.

  • People in one group have 2 weeks of aspirin
  • People in the other group have 2 weeks of ticagrelor

After this you have a break from taking aspirin or ticagrelor for 2 weeks. This is so your body can get rid of all the medication from your system. This is called a ‘wash out’.

Then those who had aspirin will have ticagrelor for 2 weeks and those who had ticagrelor will have aspirin for 2 weeks. This is called a cross over.

After this everyone will have both drugs for 2 weeks.

Study diagram

Aspirin and ticagrelor are tablets. The team will explain to you how many to take and when. You will have a diary to take home with you to record when and how many tablets you take.

The team will take blood samples

  • When you start treatment
  • 2 weeks
  • 4 weeks
  • 6 weeks
  • 8 weeks (at the end of the study)

When a number of blood samples are needed the researcher will put a small plastic tube (cannula) into a vein. This is for your comfort so that a needle won’t have to be used for each time.

The team will take the platelets from the blood sample and also look for any cancer cells in the blood (circulating cancer cells). They will use these in laboratory studies to see what impact the drugs have had on the interaction between your platelets and cancer cells.

Hospital visits

You see the doctor to have a physical examination and blood tests before taking part.

During the study you have 5 visits to the hospital to have blood samples taken. To reduce the number of extra visits needed. Where possible these blood samples will be taken at your routine hospital appointments.

A month after the end of the study, a member of the team will phone you to see how you are.

Side effects

The most common side effects of ticagrelor are

  • Bleeding more than normal from cuts or wounds
  • Nosebleed
  • Bruising
  • Shortness of breath (this usually settles after a few days)

A serious side effect is black poo (stool) or blood in your poo. If you notice either of these you need to contact your doctor straight away.

The most common side effects of aspirin are

  • Mild stomach pain and heartburn.  This can usually be avoided if aspirin is taken with food
  • Runny nose, blocked nose
  • Bleeding more than normal from cuts or wounds
  • Nosebleed
  • Bruising

Serious side effects of aspirin include

  • An allergic reaction. Signs of allergic reaction may include difficulty in breathing or swallowing, swelling of the face, lips, throat or tongue, skin rashes or itching, runny nose and itching eyes
  • Tummy (stomach) ulcer
  • A hole or tear (perforation) causing severe stomach pain
  • Black poo or blood in your poo (stool)
  • An asthma attack (only if you are asthmatic and sensitive to aspirin)

If you notice any of these you need to contact your doctor straight away.

Your doctor will talk to you about the possible side effects of ticagrelor and aspirin before you agree to take part in the study.

Location

Leicester

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 David Adlam

Supported by

AstraZeneca
ECMC
Hope Against Cancer 
NIHR Clinical Research Network: Cancer
University of Leicester
 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13458

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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