RecruitingNAINTERVENTIONAL

Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)

This research is looking into extreme tiredness caused by cancer (cancer-related fatigue) and general chronic fatigue syndrome (CFS/ME). Scientists believe that understanding these conditions better could lead to new ways to help people. They are studying different factors in the body, such as gut bacteria (microbiome), various body chemicals (metabolome and lipidome), and genetic information (exome). They will compare people with these types of fatigue to others who don't have them, including some with similar cancer but no fatigue. The study will also explore whether taking probiotics – which are beneficial bacteria often found in supplements or yoghurts – can make a difference in reducing fatigue. This is a crucial step towards finding more effective treatments for these debilitating conditions.

At a glance

Status

Recruiting

Phase

Sponsor

Universität des Saarlandes

Enrolment target

150

Start

20 Jul 2021

Estimated completion

01 Dec 2025

What is this study about?

This study is all about understanding why some people feel an extreme, long-lasting tiredness, known as fatigue. The research focuses on two main types: tiredness linked to cancer, called Cancer-Related Fatigue (CRF), and Chronic Fatigue Syndrome (CFS/ME), which is also known as Myalgic Encephalomyelitis.

Researchers want to find out what's causing this tiredness. To do this, they are closely examining several things in the body. This includes looking at the 'microbiome', which refers to the communities of tiny germs (like bacteria) living in your gut. They're also checking the 'metabolome' and 'lipidome' – these are all the different chemicals and fats found in your body. Finally, they're studying your 'exome', which is a part of your genetic information. By comparing these in people with and without fatigue, they hope to spot key differences.

Another important part of this study is testing if probiotics can help. Probiotics are often called 'good bacteria' and are found in some foods and supplements. The researchers will give some participants probiotics and others a dummy pill (placebo) to see if these good bacteria can reduce fatigue. This type of study is 'double-blinded', meaning neither the participants nor their doctors know who is getting the real probiotics, which helps make the results fairer and more reliable.

Key takeaways

Researchers are investigating severe tiredness linked to cancer (CRF) and Chronic Fatigue Syndrome (CFS/ME).
They are looking at gut bacteria, body chemicals, and genes to understand the causes.
The study explores if probiotics, known as 'good bacteria', can help reduce fatigue.
Participation involves providing samples and potentially taking study medication (probiotics or a dummy pill).
Results could lead to a better understanding and new treatments for fatigue in the future.

Who may be eligible?

To be considered for this study, you must be between 18 and 80 years old. If you have been diagnosed with cancer through tests like biopsies, cell samples, or scans, and your doctor has recommended chemotherapy, you might be eligible. It's also essential that you are willing and able to give your written consent to take part in the study.

However, this study isn't suitable for everyone. You wouldn't be able to participate if you have long-term inflammatory bowel conditions like Crohn's disease or ulcerative colitis. Also, if you are pregnant, this study is not for you.

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 between 18 and 80 years old?
Have you been diagnosed with cancer?
Has your doctor recommended chemotherapy?
Do you NOT have a long-term inflammatory bowel disease?
Are you NOT pregnant?
Are you able and willing to give written consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several visits to the clinic where researchers will collect samples from you. These samples, such as blood or stool, will help them look at your gut bacteria, body chemicals, and genetic information. If you are having abdominal surgery, they might also collect samples from inside your tummy.

You might be asked to take a specific probiotic supplement or a dummy pill (placebo) for a period of time. You won't know which one you are taking, and neither will your doctor, which is a standard way to test treatments fairly. Throughout the study, you'll be asked about your fatigue levels to see if there are any changes. The total duration of your participation will depend on the specific part of the study you are in, but the team will explain this fully before you agree to take part.

Potential risks and benefits

Participating in this study might not directly benefit you, but the information gained could greatly help future patients suffering from fatigue by leading to better understanding and possibly new treatments. As with any study, there could be some risks, such as minor discomfort from blood tests. If you are given probiotics, there's a small chance of mild stomach upset, although these are generally considered safe. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Saarland University Medical Center
Verified postcode
Homburg, Germany· Recruiting

Common questions

What is 'Cancer-Related Fatigue'?

It's an extreme, persistent tiredness linked to cancer or its treatments, which is not usually helped by rest.

What is 'Chronic Fatigue Syndrome (CFS/ME)'?

It's a serious, long-term illness that causes extreme tiredness, along with other symptoms like pain, poor sleep, and difficulty concentrating.

What are 'probiotics'?

Probiotics are live 'good bacteria' that are thought to be beneficial for your gut health and overall well-being.

Will I know if I'm taking the probiotic or the dummy pill?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know, to ensure fair results.

Will this study cure my fatigue?

This study aims to understand the causes of fatigue and explore potential treatments, but it doesn't guarantee a cure for your fatigue.

How to find out more

Michael Jelden, MD

michael.jelden@uks.eu +4968411630000 Official trial record

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