A trial to see if selenium and vitamin E can help stop early stage bladder cancer coming back (SELENIB)

Cancer type:

Bladder cancer

Status:

Results

Phase:

Other

This trial was done to find out if taking selenium and vitamin E supplements can reduce the chance of early bladder cancer coming back (recurring). 

The trial was supported by Cancer Research UK. It was open for people to join between 2007 and 2011. The team published the results in 2023.

More about this trial

Doctors usually treat non muscle invasive bladder cancer with surgery. After that, they may give 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 getting some types of cancers, including bladder cancer. But researchers wanted to find out if taking selenium and vitamin E supplements can help people who already have bladder cancer.

There were 4 treatment groups in this trial:

  • group 1 took selenium tablets and vitamin E capsules
  • group 2 took selenium tablets and dummy (placebo) capsules
  • group 3 took placebo tablets and vitamin E capsules
  • group 4 took placebo tablets and placebo capsules

They took the tablets and capsules for up to 5 years.

The main aim of this trial was to find out whether these supplements can reduce the risk of early bladder cancer coming back.

Summary of results

It took longer to find people to join the trial than the research team were expecting. They decided to close the trial a bit earlier than planned.

A total of 270 people joined the trial. They were put into a treatment group at random:

  • 69 had selenium and vitamin E
  • 65 had selenium and the vitamin E placebo
  • 71 had the selenium placebo and vitamin E
  • 65 had the selenium placebo and the vitamin E placebo

The trial team looked the number of people whose cancer had started to grow again. 

The results showed there was no difference between those who took selenium and those who didn’t. But the cancer came back in more people who took vitamin E than those who didn’t.

The trial team calculated the number of people whose cancer is not likely to come back within 5 years of joining the trial.

This was:

  • just over half (53%) of those who took selenium
  • just over half (52%) of those who didn’t take selenium
  • less than half (46%) of those who took vitamin E
  • more than half (60%) of those who didn’t take vitamin E 

They also looked at whether the cancer got worse (progressed), how many people had died and how long people lived. They found this was similar in all the groups.

Side effects
No one taking part had any side effects caused by the selenium tablets or the vitamin E capsules.

Conclusion
The trial team concluded that:

  • selenium doesn’t change the risk of bladder cancer coming back
  • vitamin E may increase the risk of bladder cancer coming back
  • neither selenium nor vitamin E affected how long people lived

Sometimes trials show that something isn’t useful for a particular type or stage of cancer. But these trials are important and still add to our knowledge and understanding of cancer and how to treat it.

More detailed information
There is more information about this research in the reference below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Selenium and Vitamin E for Prevention of Non–Muscle-Invasive Bladder Cancer Recurrence and Progression. A Randomized Clinical Trial.
R T Bryan and others
JAMA, 2023. Volume 6, issue 10. 

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

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

Professor Richard T Bryan

Supported by

Birmingham and the Black Country Comprehensive Local Research Network
Cancer Research UK
NIHR Clinical Research Network: Cancer
School of Cancer Sciences (University of Birmingham)

Other information

This is Cancer Research UK trial number CRUK/05/28.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 620

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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