RecruitingOBSERVATIONAL

Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy

This study focuses on gut problems that can happen to people with a type of blood cancer called acute myeloid leukaemia (AML) when they're having strong treatments like chemotherapy. These treatments can make the immune system very weak, leading to a low number of white blood cells (neutropenia), which increases the risk of infections. While many infections are known, gut infections and issues like neutropenic enterocolitis (NE) are not fully understood, even though they can be very serious. This study aims to find out how often these gut problems occur by carefully checking patients for symptoms and using scans. By understanding these conditions better, doctors hope to diagnose them earlier, improve treatment, and help patients recover. It's the first study of its kind to look at these specific gut problems in a detailed way within this group of patients.

At a glance

Status

Recruiting

Sponsor

Centre Hospitalier Universitaire, Amiens

Enrolment target

170

Start

14 Jan 2019

Estimated completion

13 Nov 2024

Acute Myeloid Leukemia

What is this study about?

When someone has acute myeloid leukaemia (AML) and undergoes strong treatments like chemotherapy, their body's ability to fight off infections can become very low. This is because the treatment reduces white blood cells, including 'neutrophils' which are important for immunity. When these cells are low, it's called neutropenia. During this time, people are at high risk of infections.

While doctors know a lot about general infections, problems in the gut (digestive system) are less understood, even though they can be very serious. One such problem is called neutropenic enterocolitis (NE), which is a severe inflammation of the gut. There can also be other gut issues, like infections caused by specific viruses or bacteria. Currently, doctors don't have enough clear information about how often these gut problems happen or the best way to quickly find and treat them in AML patients.

This study aims to change that. It's the first time researchers are closely watching a group of AML patients during their intensive treatment to see how often these specific gut problems arise. By doing this, they hope to learn to identify these serious gut issues earlier. An earlier diagnosis could mean patients get treated sooner, helping to prevent more serious complications and improving their chances of a better recovery. The study also wants to identify signs that might show if a patient needs more intensive care, possibly including surgery.

Key takeaways

This study looks at gut problems in people with AML during chemotherapy.
It aims to find out how common these problems are, especially a serious one called neutropenic enterocolitis.
The goal is to diagnose gut issues earlier to improve patient care.
You might have extra scans if you get a fever and gut symptoms.
It's a monitoring study, not a drug trial.
You can stop participating at any time.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 or older. You must have acute myeloid leukaemia (AML) and be well enough to have the strong chemotherapy treatments that lead to a low white blood cell count. You also need to be able to understand and agree to take part in the study, and be covered by a social security system, meaning you're a UK resident with healthcare rights.

You cannot take part if you are under 18 years old or if your AML means you can't have intensive chemotherapy. People with a specific type of AML called acute promyelocytic leukaemia are also not able to join. If you are pregnant, or have certain other medical conditions like HIV or hepatitis B or C, you would not be eligible.

Lastly, if you are under a court order that limits your freedom or decision-making, you cannot participate in this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Acute Myeloid Leukaemia (AML)?
Are you able to have strong chemotherapy treatments for your AML?
Are you able to understand and agree to take part?
Are you NOT pregnant, and do you NOT have HIV or Hepatitis B or C?
Are you NOT under any legal guardianship or court order?

Answer every question to see your result.

What does participation involve?

If you join this study, the doctors and nurses will closely monitor your gut health. During your intensive chemotherapy periods for AML, if you get a fever that lasts for at least 5 days even with antibiotics, and you also have any tummy or gut symptoms, you will have a special scan. This will be a CT scan with an injection of dye, focusing on your tummy area. This scan will happen at the same time you might be having another scan for lung infections.

Throughout your treatment, any symptoms you have, along with results from lab tests (like looking for germs) and imaging scans, will be carefully recorded. You will remain in the study until your AML becomes resistant to treatment, you need a stem cell transplant, or if you decide you no longer wish to participate. Your last study visit will be at the end of your main chemotherapy treatments (consolidation courses).

Potential risks and benefits

Participating in this study might not directly benefit you, but the information gathered could help future patients with AML by leading to earlier diagnosis and improved care for gut complications. The main risk involves having additional CT scans, which expose you to a small amount of radiation, and the injection used for the scan can have side effects for some people, although these are usually mild. You are always free to leave the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (3)

CHU Amiens-Picardie
Verified postcode
Amiens, France· Not yet recruiting
CHU de Caen
Verified postcode
Caen, France· Not yet recruiting
Henri Becquerel Center
Verified postcode
Rouen, France· Recruiting

Common questions

What is neutropenic enterocolitis (NE)?

NE is a serious inflammation of the gut that can happen when your immune system is very weak, like during strong chemotherapy for diseases such as AML.

Why is this study needed?

Currently, doctors don't know enough about how often serious gut problems happen in AML patients during treatment, or the best way to find and treat them early.

Will I get extra medicine in this study?

No, this study mainly involves extra monitoring and scans if you develop a fever and gut symptoms. It does not involve new medications.

What if I feel unwell during the study?

You will receive all your usual medical care for AML. The study adds extra checks to help understand your gut health better.

Can I stop participating in the study?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your ongoing medical treatment for AML.

How to find out more

Delphine LEBON, Doctor

lebon.delphine@chu-amiens.fr 0033 3 22 45 59 17 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.