Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at nimorazole and radiotherapy for head and neck cancer (NIMRAD)
This trial is looking at radiotherapy and the drug nimorazole for people with head and neck cancer. The trial is for people with cancer that may have spread to
Most cancers have some cells with a low level of oxygen. These are more difficult to kill with radiotherapy than cancer cells with a normal oxygen level. Nimorazole is a drug that gets into the cells with a low level of oxygen. These cells are then more likely to be killed by radiotherapy.
In this trial, doctors will compare nimorazole with a dummy drug (
The aims of the trial are to find out
- Whether giving nimorazole with radiotherapy is a better treatment than radiotherapy alone
- The side effects of nimorazole
Who can enter
You may be able to join this trial if all of the following apply
- You have a head and neck cancer that started in cells called
- Your cancer may have spread to
lymph nodesor surrounding body tissues (locally advanced cancer), but has not spread to another part of your body
- You are able to have radiotherapy
- You have satisfactory blood test results
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You can’t have chemotherapy using a
platinum drugsuch as cisplatin or drugs called monoclonal antibodies
- You are willing to use reliable contraception during treatment and for 1 week after you have finished treatment if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot join this trial if any of these apply. You
- Have cancer in your nose (nasal cavity or paranasal sinuses), mouth (oral cavity), or nasopharynx
- Have had chemotherapy in the last 6 months
- Have had radiotherapy to your head and neck before
- Have certain heart or lung conditions (your doctor can advise you about this)
- Have a low level of red blood cells (
anaemia) in the week before treatment is due to start (you may be able to have a blood transfusionto top up your red blood cells)
- Have been diagnosed with numbness or tingling particularly in your hands and feet (
- Have had an experimental drug in the last month
- Have a medical condition affecting your bowel such as Crohn’s disease or ulcerative colitis, or have had surgery to your bowel or stomach that affects your ability to absorb drugs and nutrients
- Have any other medical condition or previous cancer that could affect your taking part (your doctor can advise you about this)
- Have to take drugs called lithium or phenobarbitone
- Are breastfeeding or pregnant
This trial will recruit 470 patients in the UK. It is a randomised trial. The people taking part are put into 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.
- People in one group have radiotherapy and a dummy drug (
- People in the other group have radiotherapy and nimorazole
You have radiotherapy once a day, Monday to Friday, for 6 weeks. You take a tablet (either the dummy drug or nimorazole) every day that you have treatment. If you are unable to swallow the tablets, they can be crushed or taken through a feeding tube.
The trial team will ask you to fill in a questionnaire
- Before treatment
- 6 weeks later (or sooner if you finish the treatment early)
- Then at 6, 12, 18, 24 and 36 months after treatment has finished
The questionnaire will ask about any side effects you have and how you are feeling. This is called a quality of life questionnaire.
The researchers will ask your permission to get a sample of tissue removed when you had a
If you don’t wish to give these extra samples for research, you don’t have to. You can still take part in the trial.
The trial team will also give you a diary and ask you to write down the time you take your tablet and the time you started radiotherapy.
You will see the doctor and have some tests before you start treatment. These tests may include
You see the doctor every week during treatment. During the 4th week of the treatment, you have a blood test.
When you finish treatment, you see the doctor 6 weeks and 3 months later. After that you see them every 6 months for 2 years and then once a year for another 3 years.
You will also have either a CT or MRI scan of your head and neck 3 months after completing treatment.
All treatments have side effects. The side effects of radiotherapy to the head and neck include
- A sore or dry mouth
- Mouth ulcers
- Fungal infection of the mouth (thrush)
- Taste changes
- Difficulty swallowing
- Weight loss
- Voice changes (your voice may become hoarse or husky)
- Hair loss in the treated area
The possible side effects of nimorazole include
As with any new treatment, it is possible that there could be some side effects the doctors don’t know about yet.
How to join a clinical trial
Prof Nick Slevin
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
The Christie NHS Foundation Trust
This Cancer Research UK trial number CRUK/13/006.