"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial to see if selenium and vitamin E stop early bladder cancer from coming back (SELENIB)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is to find out if taking the supplements selenium and vitamin E reduces the chance of early bladder cancer coming back (recurring). This trial is supported by Cancer Research UK.
Doctors usually treat early stage bladder cancer with surgery. After that, you may have chemotherapy into the bladder or immunotherapy such as BCG. But sometimes the cancer comes back or starts to grow again.
Selenium and vitamin E are nutrients found in a healthy balanced diet. These nutrients may reduce the risk of people getting some types of cancers, including bladder cancer. But researchers do not know if taking selenium and vitamin E supplements can help people who already have bladder cancer.
The aim of this trial is to find out whether supplementing your normal diet with one or both of these nutrients will reduce the chance of early bladder cancer coming back.
Who can enter
You can enter this trial if you
- Have stage Tis (or CIS)], Ta or T1 bladder cancer
You cannot enter this trial if you
- Have stage T2, T3 or T4 bladder cancer
- Are pregnant or breastfeeding
- Are HIV positive
- Are taking medication that affects how well your immune system is working, following an organ transplant
- Are taking the drug cyclosporine
- Have any other medical condition which the study team think will affect the results of the study
This study will recruit people from 16 centres in and around the West Midlands. It is a randomised trial. It will recruit 515 people into 4 groups. The people taking part are put into treatment groups by computer. Neither you nor your doctor will be able to decide which group you are in, or will be told which group you are in. This is called a double blind trial. Everyone taking part will take 1 tablet and 1 gel capsule every day for up to 5 years.
If you are in group 1, you will take 1 selenium tablet and 1 vitamin E capsule daily.
If you are in group 2, you will take 1 selenium tablet and 1
If you are in group 3, you will take 1 dummy tablet and 1 vitamin E capsule daily.
If you are in group 4, you will take 1 dummy tablet and 1 dummy capsule daily.
You will have some tests when you are first diagnosed with bladder cancer. You shouldn’t need any extra tests to take part in this trial. You may be asked to give the research team a sample of your toenail clippings. They will use these to look at the level of selenium in your body. If you are taking the drug warfarin, you will need to have some extra blood tests during the first month of the trial.
You will go to the hospital to see the research nurse when you first join this trial. They will telephone you before your next appointment to ask you how you are and answer any questions.
You will then see the research nurse every 6 months whilst you are taking part in the trial. This appointment will be part of your routine follow up, so you should not need to make any extra trips to the hospital as part of the trial.
The appointment with the research nurse should take about 15 minutes. They will give you the study treatment for the next 6 months, and they will ask you how you are and if anything has changed since they saw you last.
At one of these appointments, you may have a blood test, and the research nurse may ask you for a sample of your toenail clippings. The researchers want to see if the vitamin and mineral levels in your body have changed since taking the study treatment.
The doses of selenium and vitamin E in this trial should not cause any side effects.
It is important that you do not take any other selenium or vitamin E supplements as well as your study treatments. This could cause side effects, and would also affect the results of the trial. If you take any multivitamin tablets, and you are not sure if they contain selenium or vitamin E, you should check with the research nurse.
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.
Dr RT Bryan
Birmingham and the Black Country Comprehensive Local Research Network
Cancer Research UK
NIHR Clinical Research Network: Cancer
School of Cancer Sciences (University of Birmingham)
This is Cancer Research UK trial number CRUK/05/28.