A study looking at cognitive changes in women having chemotherapy for breast cancer (Chemobrain)
Cancer type:
Status:
Phase:
This study is looking at how chemotherapy can affect thinking, concentration and memory. These problems are called cognitive changes.
It is for women who have had or are having chemotherapy for early breast cancer that has not spread to other parts of the body. The team are also looking for healthy volunteers to take part.
More about this trial
One of the possible side effects of chemotherapy is problems with thinking. You might also have memory loss or find it difficult to concentrate. These are called cognitive changes or cognitive impairment. You might hear this called chemo brain.
It’s not clear what causes these cognitive changes in people with cancer. They do get better or improve in most people. Some are left with permanent memory problems affecting their 
.
Many of the signs and symptoms of chemo brain are similar to people who have conditions such as Alzheimer’s disease. We know from research into Alzheimer’s disease that and show it is possible to detect changes in the brain. This is before people show signs of memory problems. Researchers found higher levels of a protein called tau in the brain in people with early Alzheimer’s. The scans also showed they have changes to the border between the brain and the body. This is called the blood brain barrier.
Researchers would like to see if it’s possible to use these scans to look for changes in the brain in people having chemotherapy for early breast cancer. The team will also use tests that measure thinking skills (cognitive tests).
The main aim of this study is to learn more about how chemotherapy affects the thinking skills of women with early breast cancer.
Please note - you won’t get any direct benefit from joining this study but it may help to find out more about these cognitive changes.
Who can enter
The following bullet points are a summary of 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
For breast cancer
You may be able to join this study if all of the following apply. You:
- are a woman who has been diagnosed with breast cancer
- are due to have or have had chemotherapy in the last 12 months that included the chemotherapy drugs doxorubicin or epirubicin. And you have had another type of chemotherapy that included paclitaxel or docetaxel.
- are up and about more than half the day, you can look after yourself but might not be able to work (performance status 0, 1 or 2)
- are at least 18 years old
For healthy volunteers
You may be able to join if you are at least 18 years old
Who can’t take part
For people with breast cancer
You cannot join this study if any of these apply. You:
- have major depression
- have or had a significant medical condition or there is another reason that could affect you taking part
- have had electroconvulsive therapy (ECT) in the past
- are pregnant or breastfeeding
For healthy volunteers
You cannot join this study if any of these apply. You:
- have major depression
- have known memory problems, cognitive impairment or dementia
- have or had a significant medical condition or there is another reason that could affect you taking part
Trial design
The team need about 500 women with early breast cancer to take part. They also need about 200 healthy volunteers to join.
The team recruit people to take part from outpatient clinics in hospitals around the country. There will also be information about the study on the internet and posts on social media. There will be a contact address for the study team if you are interested in taking part.
The team can tell you more about the study if you contact them. They check if you are suitable to take part. If you are suitable, they ask you to complete a questionnaire and a short memory test. This takes about 30 minutes. You do this online.
Healthy volunteer group
You complete some memory tests online. You do these once. The study team email you a link to do this. Each test has clear instructions with video demonstrations and practice rounds. The tests are designed to check cognitive abilities. These include testing your memory, verbal skills and concentration. The tests take about 60 minutes in total.
You may also be invited to complete some more detailed memory and mental tests. These are done at Hammersmith Hospital in London. These tests take up to 3 hours in total. You have short breaks in the session so it’s not too tiring. The team will also ask to take a blood sample. You don’t have to agree to do the memory tests at the hospital or have the blood sample taken. This won’t affect you taking part in the rest of the study.
You don’t have any scans if you are a healthy volunteer.
Breast cancer group
You complete some memory tests online. They are the same tests that the healthy volunteer group do. You do the memory tests every 3 months for up to one year.
You may also be invited to complete some more detailed memory and mental tests. These are done at Hammersmith Hospital in London. These tests take up to 3 hours in total. You have short breaks in the session so it’s not too tiring.
The team might also ask you to have some brain scans. You can say no to having the scans if you don’t want to. If you agree to have the scans you have them at Hammersmith Hospital. The scans include:
- MRI scan
- Dynamic Contrast-Enhanced MRI (DCE-MRI)
- PET-CT scan
The MRI scan takes about 60 minutes. It takes an extra 15 minutes if you also agree to the DCE-MRI scan. You have these scans at the same time. For the DCE-MRI scan you have a . You have this as an injection into a vein. The contrast dye gives a more detailed picture of the border between your brain and body.
The PET-CT scan is a separate scan. You have an injection of a radioactive dye (tracer). You have this as a drip into a vein. You then wait for about an hour before having the scan.
The team also ask to take a blood sample. You can say no to giving the blood sample if you don’t want to. It won’t affect you taking part in the rest of the study.
Both groups
The team will refer you to a specialist memory clinic for further help if you show signs of memory problems. They will discuss this with you and let your GP know so they can offer you any support you need.
Hospital visits
You have the scans at Hammersmith Hospital in London. If possible, you have them on the same day. This depends on the availability of the scanners. So you might need to have them done on separate days.
You have the blood sample taken at Hammersmith Hospital if you have this.
You also have a hospital visit if you agree to do some of the memory tests at the hospital.
Side effects
Sometimes the contrast dye used in the DCE-MRI scan can cause you to:
- feel sick
- develop a skin rash
- develop headaches, dizziness or both
These side effects are usually mild and don’t last long.
The PET-CT scan uses a radioactive dye and this gives a small amount of radiation. The amount of radiation is kept to the minimum needed for the test. There are usually no reactions or side effects from PET scans.
You may have some discomfort, bruising and slight bleeding from the blood test.
We have information about having a PET-CT scan and an MRI scan.
The study team might find problems with your memory and attention. Finding out that you have problems with your thinking can be upsetting. But the team will be able to ask your GP to investigate this, so that you can get the support you need.
Location
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.
Chief Investigator
Dr Laura Kenny
Supported by
Imperial College London
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
