
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
This trial is looking at whether hydrogen peroxide can make breast cancer more sensitive to radiotherapy. This could make the radiotherapy work better.
The trial is open to people with breast cancer that:
Doctors use radiotherapy to shrink breast cancer. This can help control the symptoms.
In this trial researchers are using KORTUC (hydrogen peroxide contained within a gel) with radiotherapy.
Hydrogen peroxide is a household antiseptic. People sometimes use it to clean and sterilise cuts and grazes. KORTUC is a weakened (diluted) form of hydrogen peroxide mixed with a gel. It is 6 times weaker than the hydrogen peroxide that we use at home.
KORTUC is injected into the cancer before you have radiotherapy. Once in the cancer the gel slowly releases the hydrogen peroxide into the cancer. The hydrogen peroxide breaks down into oxygen and water. So none of the hydrogen peroxide goes into your bloodstream.
Research shows that KORTUC might work for people with breast cancer. To find this out half the people in this trial have KORTUC with their radiotherapy and half have radiotherapy on its own.
The main aim of this trial is to find out how well KORTUC with radiotherapy works compared to radiotherapy on its own.
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:
Who can’t take part
You cannot join this trial if any of these apply. You:
This a phase 2 trial the team need a 184 people to join.
It is a randomised trial. There are 2 groups. Neither you nor your doctor chooses which group you are in. The 2 groups are:
You have a planning appointment before starting radiotherapy. This so the radiotherapy team can work out the dose and where you need it.
As part of the trial everyone has an MRI scan before they start their radiotherapy treatment. This so the team can accurately measure the size of your cancer.
KORTUC is hydrogen peroxide in a slow release gel. You have the gel injected into the cancer before having radiotherapy.
A specialist member of staff injects the hydrogen peroxide. Before the injection you have a to numb the area of skin. A staff member uses an
to guide where to give the injection. This takes 10 to 15 minutes. The gel slowly releases the hydrogen peroxide over 1 to 2 days after each injection.
You start having the injections on the 2nd week of radiotherapy. You have the injection before your radiotherapy. You have 4 to 6 doses over 2 to 3 weeks. This means that you have 2 injections a week.
MRI sub study
This is an extra scan you have at the end of your routine MRI scan. It adds an extra 6 minutes to the scan. You have it at:
You also have an extra MRI scan at the end of your radiotherapy. This takes about 30 minutes.
The aim of this sub study is to:
Ultrasound sub study
This sub study is only open to people having treatment at the Royal Marsden Hospital.
Imperial College London Hospital has developed a new 3 dimensional (3D) ultrasound technique that looks at how blood flows through cancers. This ultrasound scan takes about 20 minutes. You have it:
They hope this ultrasound scan along with the MRI scan can improve doctor’s ability to work out how well the treatment is working.
Blood and tissue samples for research
You give extra blood samples 4 times during the trial.
The team ask to get a piece of the tissue sample from routine hospital tests.
You give 2 extra tissue samples:
Researchers use these blood and tissue samples to:
You can choose if you want to take part in the sub studies and if you want to give both or either of the samples.
You see the doctor for tests before taking part. These tests include:
After your radiotherapy you see the doctor at:
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.
You might have some mild pain in the area of cancer where you have the injection. This can last between a few minutes and several hours after the injection.
There is a very small chance you might get a mild form of tumour lysis syndrome. This happens when KORTUC breaks down the cancer faster than it takes the body to get rid of the waste products caused by the breakdown. The symptoms include:
Contact your health team or advice line straight away if you have any of these symptoms after having KORTUC.
We have information about radiotherapy to the breast.
Your doctor or a member of the trial team will talk to you about the possible side effects of the treatments before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Navita Somaiah
Institute of Cancer Research (ICR)
CRUK Convergence Science Centre
Kortuc Inc
Freephone 0808 800 4040
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”