A trial looking at treating anaemia before surgery for bowel cancer (IVICA)

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Cancer type:

Bowel (colorectal) cancer
Colon cancer
Rectal cancer

Status:

Results

Phase:

Phase 4

This trial compared 2 ways of giving iron supplements to people with a low red blood cell count due to bowel cancer. A low red blood cell count is called anaemia. 

More about this trial

Doctors usually treat bowel cancer with surgery. They know that people who have anaemia before surgery can take longer to recover. 
 
The usual treatment for anaemia before surgery is iron tablets. But they have side effects such as constipation and many people stop taking them. This means some people need a blood transfusion before and after surgery. 
 
In this trial, doctors looked at another way of giving iron. This was as a drip into a vein (an infusion). Researchers wanted to see how well this worked to treat anaemia. And if it reduced the amount of blood transfusions.
 
Some people had iron tablets as usual. And some had an iron infusion. 
The aims of this trial were to:
  • find out which treatment worked best
  • learn more about the side effects

Summary of results

The researchers found that having an iron infusion didn’t reduce the number of people who needed a blood transfusion. But it worked better than tablets to treat anaemia. 
 
This trial was open for people to join between 2012 and 2014. The results were published in 2017.
 
About this trial
This was a phase 4 trial. 116 people took part. 
 
It included:
  • women whose red blood cell level (haemoglobin) was less than 11
  • men whose red blood cell level was less than 12
They were put into 1 of 2 groups at random
 
At least 14 days before surgery:
  • 61 people had tablets 
  • 55 people had iron as a drip (an infusion)

45 out of the 55 people who had an infusion needed a second one. 
 
Results
The researchers looked at:
  • how many people had blood transfusions
  • the amount (volume) of blood they had 
On average, the levels of red blood cells were about the same between the groups before treatment started. 
 
But the researchers found that people who had the infusions had a higher level of red blood cells after treatment. This meant that they were less anaemic at the time of surgery.
 
2 people had a blood transfusion before surgery. Both were in the group who had tablets. 6 people in each group had a transfusion on the day of surgery.
 
At surgery:
  • 55 out of 61 people who had tablets were anaemic
  • 41 out of 55 people who had the injections were anaemic
After surgery, 30 people who had tablets needed more iron tablets. This was compared to only 4 people in the infusion group. 
 
Side effects
Side effects of iron are usually mild. 3 people who had an infusion had a headache afterwards. 1 person had a severe skin rash, but this was easy to treat. 
 
Conclusion
The trial team concluded that the infusion worked better than iron tablets to treat anaemia. But it didn’t reduce the amount of blood transfusions. Although they do say that maybe having the infusion earlier would work better. 
 
Iron infusions are more expensive than tablets. And taking tablets is a much simpler option. So, the researchers think they need to do more research into iron infusions before they recommend this as a standard treatment Open a glossary item.
 
Where do these results come from 
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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

Mr Austin Acheson

Supported by

NIHR Clinical Research Network: Cancer
Nottingham University Hospitals NHS Trust

 

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Last review date

CRUK internal database number:

8741

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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