RecruitingNAINTERVENTIONAL

The Effects of a Food Product Containing Mushroom Extracts (AndoSanTM) in Subjects with Colorectal Cancer-related Fatigue

This study is investigating a special liquid food product named AndoSanTM, which contains extracts from different types of mushrooms. The main goal is to find out if AndoSanTM can help reduce the severe tiredness (fatigue) often experienced by people who have had bowel cancer (colorectal cancer). Researchers also want to see if taking AndoSanTM improves how people feel about their overall health and well-being, known as their quality of life. They will also check for any changes in the body that might show a reduction in inflammation, and importantly, ensure that AndoSanTM is safe to use and well-tolerated by participants. This is a pilot study, meaning it's an initial investigation in a small group of people.

At a glance

Status

Recruiting

Phase

Sponsor

Mycotech Pharma AS

Enrolment target

Start

09 Sep 2024

Estimated completion

01 Feb 2025

Cancer-related Fatigue

What is this study about?

This research is looking into a product called AndoSanTM. It's a special liquid food made from fermented extracts of three different types of mushrooms: Agaricus subrufesence, Hericium erinaceus, and Grifola frondosa. Many people who have had bowel cancer, also known as colorectal cancer, experience long-lasting and severe tiredness, often called cancer-related fatigue. This fatigue can make daily life very difficult.

The main aim of this study is to see if AndoSanTM can help people with this type of fatigue feel less tired. The researchers will be closely monitoring how participants' tiredness levels change over time while using AndoSanTM. They also want to understand if taking AndoSanTM can improve a person's overall quality of life – meaning how well they feel, their mood, and how easily they can do daily activities.

Beyond just feeling less tired, the study will also investigate if AndoSanTM affects certain markers in the body that indicate inflammation. Inflammation is a natural process, but long-term inflammation can sometimes be linked to fatigue. Finally, and very importantly, the study will carefully check for any side effects or problems that people might have while taking AndoSanTM, to make sure it's safe to use.

Key takeaways

This study evaluates a mushroom-based liquid called AndoSanTM for cancer-related fatigue.
It's for people aged 18-65 with bowel cancer (stages I-III) and ongoing fatigue.
The main goal is to see if AndoSanTM reduces tiredness and improves quality of life.
The study will also check for safety, side effects, and changes in inflammation.
Participants must have completed cancer treatments and be experiencing stable fatigue.

Who may be eligible?

This study is looking for men and women between the ages of 18 and 65 years old. To join, you must be of European (Caucasian) descent and have been diagnosed with bowel cancer (colorectal cancer) that has not spread to other parts of your body (stages I-III). A key requirement is that you must be experiencing persistent, moderate to severe tiredness linked to your cancer, which has been present for at least four weeks and is at a stable level. Also, you must have finished all your cancer treatments (like chemotherapy or radiotherapy) at least four weeks before the study starts, and any cancer surgery must have been at least six weeks prior.

You cannot take part if your cancer is getting worse quickly, or if you need to start new cancer treatments. Women who could become pregnant must be willing to use reliable contraception during the study. You also need to be able to follow all the study instructions, including how and when to take AndoSanTM. The researchers will make sure you meet all these requirements before you can officially join.

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 65 years old?
Do you identify as Caucasian?
Have you been diagnosed with bowel cancer (colorectal cancer) that has not spread (stages I-III)?
Have you been experiencing constant, moderate to severe tiredness (fatigue) for at least 4 weeks?
Have you finished your cancer treatments (like chemo/radiotherapy) at least 4 weeks ago, and any surgeries at least 6 weeks ago?
Are you able to follow all study instructions, including taking the study product?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be asked to take a liquid food product called AndoSanTM. The study will involve several visits to the clinic where you will be assessed. At these visits, researchers will ask you questions about your tiredness and how you are feeling generally to understand any changes in your quality of life. They will also take blood samples to check for certain markers in your body, such as C-reactive protein, which can indicate inflammation.

Throughout the study, you will need to keep your usual lifestyle steady, including your exercise, work, and eating habits. This helps the researchers understand the effects of AndoSanTM without other factors changing things. The total duration of your participation in the study will be explained to you, as will how often you need to take AndoSanTM and for how long. You will receive detailed instructions on everything you need to do.

Potential risks and benefits

Participating in this study might offer potential benefits, such as a reduction in your cancer-related fatigue and an improvement in your overall quality of life. However, these benefits are not guaranteed, as the study is designed to find out if AndoSanTM works. Potential risks could include mild side effects from taking AndoSanTM, although the product is generally considered safe. All possible risks will be fully explained to you before you decide to join. Remember, taking part in any study is entirely voluntary, and you are free to withdraw at any time without giving a reason, and this will not affect your usual medical care.

Locations (3)

BioTeSys GmbH
Verified postcode
Esslingen am Neckar, Germany· Recruiting
BioTeSys
Verified postcode
Esslingen am Neckar, Germany· Recruiting
analyze & realize GmbH
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is AndoSanTM?

AndoSanTM is a liquid food product made from fermented extracts of three different types of mushrooms.

Who can join this study?

Men and women aged 18-65 who have had bowel cancer and are experiencing moderate to severe constant fatigue can join.

What is 'cancer-related fatigue'?

It's extreme, persistent tiredness linked to cancer or its treatment that isn't relieved by rest.

Will I have to do anything special during the study?

You'll take AndoSanTM, have clinic visits for assessments, and aim to keep your daily routines like diet and exercise the same.

What might be the benefits of joining?

You might experience less fatigue and feel better overall, but the study is designed to find out if this is the case.

How to find out more

Daniel Menzel

d.menzel@biotesys.de +49 71131057150 Official trial record

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