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

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)

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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.