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A trial looking at treating anaemia before surgery for bowel cancer

This trial is comparing 2 different iron supplements for people with a low red blood cell count (anaemia) due to bowel cancer (colorectal cancer).

Doctors usually treat bowel cancer with surgery. They know that people who have a low number of red blood cells (anaemia) before surgery can take longer to recover.

The standard treatment for anaemia before surgery is iron tablets. But iron tablets have side effects and many people stop taking them. So some people need a blood transfusion before surgery and during their stay in hospital.

Doctors want to look at a new iron supplement injection to find out if it can reduce the amount of blood transfusions needed.

The aims of this trial are to find out

  • If an iron supplement injection can reduce blood transfusions
  • If the iron supplement injection is better than iron tablets
  • About the side effects

Recruitment

Start 22/05/2012
End 30/08/2014

Phase

Phase 4

Who can enter

You may be able to enter this trial if you

  • Have bowel cancer
  • Have low red blood cells (anaemia) but do not need a blood transfusion
  • Are able to have surgery for your bowel cancer
  • Are at least 18 years old

You cannot enter this trial if

  • You need emergency surgery in the next 2 weeks
  • You have raised iron levels in your blood - your doctor can tell you this
  • You have had major bowel surgery in the past
  • You have anaemia not caused by your cancer
  • You are having chemotherapy
  • You are allergic to iron supplements
  • Your liver or kidneys are not working properly
  • You have any condition that would make it unsafe for you to take part in this trial
  • You have had medication as part of another trial in the last 12 weeks
  • You are going to donate blood during the trial
  • You are pregnant of breast feeding

Trial design

This trial will recruit 116 people from the UK. This is a randomised trial. The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

People in group 1 have iron (ferrous sulphate) tablets. You start taking these at least 14 days before your surgery.

People in group 2 have an iron supplement called ferinject. You have ferinject through a drip into a vein at least 2 weeks before your surgery.

The trial team will ask you to fill out questionnaires

  • Before you start treatment
  • Just before your surgery
  • Between 6 and 12 weeks after surgery

This is called a quality of life study.

Taking part in this trial will not change the surgery you have. Your surgeon will discuss your operation with you.  

If you agree to take part in this trial, the researchers will ask for a sample of tissue taken during the surgery to remove your cancer. They will use this to find out more about anaemia and cancer in the future. If you don’t want to give tissue samples for this study, you don’t have to. You can still take part in the trial.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

  • Physical examination
  • Blood pressure recording
  • Blood tests

You will have another blood test

  • On the day of your operation
  • A few days after your operation
  • And 6 to 12 weeks later

This is the end of your participation in the trial.

Side effects

The most common side effects of ferinject are

  • Headaches
  • Feeling dizzy
  • Feeling and being sick
  • Diarrhoea
  • A rash
  • Stomach ache

The most common side effects of ferrous sulphate are

  • Constipation
  • Upset stomach
  • Black stools

There is more information about surgery for bowel cancer.

Location of trial

  • Birmingham
  • Bristol
  • Derby
  • Nottingham
  • Wolverhampton
  • Yeovil

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Mr Austin Acheson

Supported by

NIHR Clinical Research Network: Cancer
NIHR Research for Patient Benefit (RfPB) Programme
Nottingham University Hospital NHS Trust
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Updated: 4 June 2014