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Could a mushroom drink fight cancer fatigue?

NCT ID NCT06599710

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This pilot study investigates whether a liquid food product made from fermented mushroom extracts (AndoSanTM) can reduce fatigue in people who have had colorectal cancer. Participants with persistent moderate-to-severe fatigue will take the supplement for six weeks. Researchers will measure changes in fatigue levels and quality of life using standard questionnaires.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AndoSanTM (fermented mushroom extract blend)
What this could lead to
If effective, this mushroom-based drink could offer a natural way to ease cancer-related fatigue and improve daily life for colorectal cancer survivors.
What could go wrong
This is a small pilot study with no placebo group, so results may not be conclusive. The supplement is not a treatment for cancer itself, and individual responses may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Started

Sep 2024

Expected to finish

Feb 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males and females from 18 to 65 years of age 2. Caucasian 3. Diagnosis of non-metastatic colorectal cancer (stages I-III) (documented) 4. Diagnosis of persistent cancer-related fatigue with moderate or severe symptoms of cancer-related fatigue (≥ 4 on 0-10 Numerical Rating Scale (NRS) and a Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Fatigue subscale (FACIT-F FS) score of ≤ 34 for assessment of average fatigue in the week before visit 1, both assessed at visit 1) 5. Cancer-related fatigue present since at least 4 weeks before visit one at a stable level (self-reported) 6. Cancer treatment completed (as reported by the attending physician before the study) considering the following conditions: * a minimum of 4 weeks after the end of the last cancer-related therapy (e.g. chemotherapy, radiotherapy) * a minimum of 6 weeks after any cancer-related surgery (if any) 7. Serum C-reactive protein (CRP) levels greater than 3 mg/l at visit1/ Screening 8. Stable medication for comorbidities (if any) 9. Established cancer-related fatigue management regime in line with current guidelines, if any, since at least 4 weeks (e.g., physical exercise counseling, medication/supplementation, nutritional counseling, psychosocial counseling) 10. Expectedly to keep level of activity (including e.g. work/educational activities, physical activity) and dietary habits during the study, including caffeine consumption and liquid intake 11. Negative pregnancy test at V1 and willingness to use a reliable method of contraception during the study in women of childbearing potential 12. Readiness and ability to understand and comply with study requirements as judged by the investigator (to take the IP as recommended) Exclusion Criteria 1. Rapidly progressing cancer without reasonable treatment options and/or serious worsening of cancer disease during the study, as well as the need for any cancer treatment that expectedly may need to start and/or cancer-related fatigue management that expectedly may need to start/get modified during the study 2. Severe anemia (hemoglobin (Hb) ≤ 8 g/dl within last 2 weeks before or at visit 1 3. Acute illness or uncontrolled chronic metabolic illness (including diabetes mellitus, hyperthyroidism, hypothyroidism, and excluding adequately medicated hypothyroidism), uncontrolled pain, and other disorders known to cause fatigue complaints (such as heart failure, chronic obstructive pulmonary disease (COPD), severe deconditioning and/or sarcopenia, severe and unresponsive inflammation, severe damage of gastrointestinal organs impairing oral food intake and digestion, parenteral nutrition, decreased calorie intake due to substantial appetite loss), all as per investigator's judgment 4. Psychiatric disorders, including recently occurred (within the last 12 weeks before visit 1) or severe depression as judged by the investigator (stable treatment with low-dose selective serotonin reuptake inhibitors (SSRIs) is permitted) 5. Known HIV infection, hepatitis B or C, or active tuberculosis (self-reported) 6. Major surgery within 4 weeks before study or planned surgery during the treatment period 7. Consuming any other food supplements / FSMPs during the study, e.g. ginseng, guarana, mistletoe 8. History of or current abuse of medication, e.g. opioids, drugs, or alcohol 9. Participation in another study during the last 30 days before and during the study 10. Breastfeeding 11. Any other reason for exclusion as per the investigator's judgment, e.g. hypersensitivity or allergy to the IP, (expected) insufficient compliance with study procedures (due to substantial cognitive complaints related to cancer-related fatigue or other cause)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • BioTeSys

    Esslingen am Neckar, Baden-Wurttemberg, 73728, Germany

  • BioTeSys GmbH

    Esslingen am Neckar, Baden-Wurttemberg, 73728, Germany

  • analyze & realize GmbH

    Berlin, State of Berlin, 10369, Germany

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