A study looking at treatment to prevent skin cancer in people who have had an organ transplant (SPOT study)

Cancer type:

Non melanoma skin cancer
Skin cancer
Squamous cell skin cancer

Status:

Results

Phase:

Phase 2

This study compared different treatments to prevent squamous cell skin cancer in people who have had an organ transplant. It was for people with a skin condition called actinic keratosis (AK) Open a glossary item The plural is actinic keratoses.

This study was open for people to join between 2015 and 2016. The team published the results in 2022.

More about this trial

Actinic keratoses (AK) are small red rough patches of skin that can develop after intense or prolonged exposure to the sun. It is not cancer. But there is a small risk that it can turn into squamous cell skin cancer if it isn’t treated.

People who have had an organ transplant Open a glossary item are at a higher risk of developing AK. This is because they take medicines to damp down (suppress) their immune system.

There are different treatments for AK. These include two creams that are applied to the skin:

Imiquimod stimulates the immune system to recognise abnormal cells and release chemicals. These chemicals (cytokines) help destroy or slow the growth of the abnormal cells.

Researchers wanted to compare both of these to using sunscreen. They hoped that treating AK may reduce the risk of skin cancer in people who’ve had an organ transplant.

This was a feasibility study. The main aims were to find out:

  • which treatment is best at preventing skin cancer  
  • what effect these treatments have on people’s quality of life
  • whether it’s possible to run a larger trial

Summary of results

This study was for people who’d had an organ transplant and had 10 or more areas of actinic keratoses (AK).

They were put into 1 of 3 groups at random. All 3 groups used sunscreen. One group also used fluorouracil (5FU) cream. Another group used imiquimod cream.

They used the creams for 4 weeks. Then had no treatment for 4 weeks. And then used the creams for another 4 weeks.

The research team looked at how many areas of AK had gone, and whether any new ones developed.

Results
The research team asked 72 people if they’d be happy to take part. A total of 48 agreed, and 40 of these (56%) joined the study. 

They were put into 1 of 3 groups:

  • 13 people used 5FU and sunscreen
  • 14 people used imiquimod and sunscreen
  • 13 people used sunscreen only

The people taking part had 903 areas of AK in total. The research team looked at how many areas of AK had gone, 12 months after starting treatment. 

They found it was:

  • more than 7 out of 10 (73%) for those who used 5FU and sunscreen
  • nearly 6 out of 10 (59%) for those who used imiquimod and sunscreen
  • nearly 4 out of 10 (39%) for those who used sunscreen only

They also looked at how many people developed new areas of AK. They found this was low in all groups, but lowest for those who used 5FU.

Side effects
Everyone who used 5FU and most people who used imiquimod had side effects such as red or sore skin where they applied the cream. But there was no difference in quality of life Open a glossary item scores between the groups.

Conclusion
The team concluded that it would be possible to run a larger trial looking at treatment for AK in people who’ve had an organ transplant. They also suggest that 5FU is better than imiquimod or sunscreen for treating AK in this group of patients. They recommend more trials are done.

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

Please note, this article is not in plain English. It has been written for health care professionals and researchers.

Topical treatment of actinic keratoses in organ transplant recipients: a feasibility study for SPOT (Squamous cell carcinoma Prevention in Organ transplant recipients using Topical treatments)
Zeeshaan-Ul Hasan and others
British Journal of Dermatology, 2022. Volume 187, issue 3, pages 324 – 327.

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 Catherine Harwood

Supported by

British Association of Dermatologists 
Meda Pharmaceuticals
National Cancer Research Institute Skin Cancer Clinical Studies Group
NIHR Clinical Research Network: Cancer
NIHR Research for Patient Benefit (RfPB) Programme
Queen Mary University of London
UK Dermatology Clinical Trials Network (UK DCTN)
University of Birmingham
University of Nottingham

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

9309

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think