Cancer-related FatigueNCT06599710
The Effects of a Food Product Containing Mushroom Extracts (AndoSanTM) in Subjects With Colorectal Cancer-related Fatigue
A study testing AndoSanTM in people with Cancer-related Fatigue, run by Mycotech Pharma AS at 3 sites in Germany.
Trial summary
Effects of a food product containing mushroom extracts (AndoSanTM) in subjects with colorectal cancer-related fatigue. AndoSanTM is a specialized liquid food product that includes fermented extracts from the fungi Agaricus subrufesence (Agaricus blazei Murill), Hericium erinaceus, and Grifola frondosa as the main… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer-related Fatigue
- What is being tested?
- AndoSanTM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesGermany
- Study dates
- 9 Sep 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females from 18 to 65 years of age
- Caucasian
- Diagnosis of non-metastatic colorectal cancer (stages I-III) (documented)
- 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)
- Cancer-related fatigue present since at least 4 weeks before visit one at a stable level (self-reported)
- Cancer treatment completed (as reported by the attending physician before the study) considering the following conditions:
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- 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)
- Serum C-reactive protein (CRP) levels greater than 3 mg/l at visit1/ Screening
- Stable medication for comorbidities (if any)
- 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)
- 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
- Negative pregnancy test at V1 and willingness to use a reliable method of contraception during the study in women of childbearing potential
- Readiness and ability to understand and comply with study requirements as judged by the investigator (to take the IP as recommended)
Who cannot join
- 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
- Severe anemia (hemoglobin (Hb) ≤ 8 g/dl within last 2 weeks before or at visit 1
- 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
- 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)
- Known HIV infection, hepatitis B or C, or active tuberculosis (self-reported)
- Major surgery within 4 weeks before study or planned surgery during the treatment period
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- Consuming any other food supplements / FSMPs during the study, e.g. ginseng, guarana, mistletoe
- History of or current abuse of medication, e.g. opioids, drugs, or alcohol
- Participation in another study during the last 30 days before and during the study
- Breastfeeding
- 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)
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
analyze & realize GmbH
Berlin, State of Berlin, 10369
BioTeSys GmbH
Esslingen am Neckar, Baden-Wurttemberg, 73728
BioTeSys
Esslingen am Neckar, Baden-Wurttemberg, 73728
About this study
Official title: Pilot Study to Evaluate the Effects of a Food Product Containing Mushroom Extracts (AndosanTM) in Subjects With Colorectal Cancer-Related Fatigue
Effects of a food product containing mushroom extracts (AndoSanTM) in subjects with colorectal cancer-related fatigue.
AndoSanTM is a specialized liquid food product that includes fermented extracts from the fungi Agaricus subrufesence (Agaricus blazei Murill), Hericium erinaceus, and Grifola frondosa as the main ingredients.
The primary study objective is to assess the change in complaints about cancer-related fatigue while taking AndoSanTM. Further objectives are to evaluate the change in health-related quality of life (QoL) and levels
Read the detailed description
Pilot study to evaluate the effects of a food product containing mushroom extracts (AndoSanTM) in subjects with colorectal cancer-related fatigue.
AndoSanTM is a specialized liquid food product that includes fermented extracts from the fungi Agaricus subrufesence (Agaricus blazei Murill), Hericium erinaceus, and Grifola frondosa as the main ingredients.
The primary study objective is to assess the change in complaints related to cancer-related fatigue while taking AndoSanTM. Further objectives are to evaluate the change in health-related quality of life (QoL) and levels of inflammation markers, as well as its safety and tolerability while taking AndoSanTM.
- Conditions
- Cancer-related Fatigue
- Being tested
- AndoSanTM
- Keywords
- Cancer-related fatigue, Colorectal cancer, Andosan, Agaricus blazei Murill, Hericium erinaceus, Agaricus subrufesence, Mushroom extract, Grifola frondosa, Chronic inflammation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndoSanTMDietary supplement
Fermented water-based exctract of Agaricus subrufesence, Hericum erinacus, and Grifola frondosa
| Study group | Role | What they receive |
|---|---|---|
| AndoSan 6 week intervention | Other | Intervention; AndoSanTM, 60 ml/day for 6 weeks Receives: Dietary Supplement: AndoSanTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the level of cancer-related fatigue after 6 weeks IP intake, in comparison to the baseline.
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Fatigue Subscale (FS): The FACIT-F FS is a subscale that measures the level of fatigue in patients, particularly those with chronic illnesses like cancer. The subscale consists of a set of questions scored on a scale from 0 to 52, with higher scores indicating less fatigue and therefore a better outcome. A score of 0 would indicate severe fatigue, while a score of 52 reflects minimal to no fatigue.
Measured: 6 weeks
Secondary outcomes (1)
Further difference in the level of cancer-related fatigue after 6 weeks IP intake, in comparison to the baseline.
The difference in cancer-related fatigue after 3 weeks and after 6 weeks, each in comparison to the baseline: Cancer-related fatigue is assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Fatigue Subscale (FS). This scale ranges from 0 to 52, where higher scores indicate a better outcome.
The differences in health-related Quality of Life (QoL) using the FACIT-F subscales relating to physical, social/family, emotional, and functional well-Health-related QoL is measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscales, which cover physical, social/family, emotional, and functional well-being. Each subscale has its own scoring range (typically 0 to 28) where higher scores indicate a better outcome.
The analysis compares fatigue levels at 3 and 6 weeks to the baseline, with changes in scores reflecting either improvement or worsening of fatigue symptoms over time.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Sep 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm pilot nutritional study, multicentric
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mycotech Pharma AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599710
- Sponsor's protocol ID
- BTS2088/24
- Status last verified
- Jul 2026
- First submitted
- 13 Sep 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data might not be shared due to intellectual property concerns.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Effects of a Food Product Containing Mushroom Extracts (AndosanTM) in Subjects With Colorectal Cancer-Related Fatigue
- ClinicalTrials.gov ID
- NCT06599710
- Acronym / sponsor ID
- BTS2088/24
- Conditions
- Cancer-related Fatigue
- Keywords
- Cancer-related fatigue, Colorectal cancer, Andosan, Agaricus blazei Murill, Hericium erinaceus, Agaricus subrufesence, Mushroom extract, Grifola frondosa
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mycotech Pharma ASIndustry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effects of a food product containing mushroom extracts (AndoSanTM) in subjects with colorectal cancer-related fatigue.
AndoSanTM is a specialized liquid food product that includes fermented extracts from the fungi Agaricus subrufesence (Agaricus blazei Murill), Hericium erinaceus, and Grifola frondosa as the main ingredients.
The primary study objective is to assess the change in complaints about cancer-related fatigue while taking AndoSanTM. Further objectives are to evaluate the change in health-related quality of life (QoL) and levels
Detailed description
Pilot study to evaluate the effects of a food product containing mushroom extracts (AndoSanTM) in subjects with colorectal cancer-related fatigue.
AndoSanTM is a specialized liquid food product that includes fermented extracts from the fungi Agaricus subrufesence (Agaricus blazei Murill), Hericium erinaceus, and Grifola frondosa as the main ingredients.
The primary study objective is to assess the change in complaints related to cancer-related fatigue while taking AndoSanTM. Further objectives are to evaluate the change in health-related quality of life (QoL) and levels of inflammation markers, as well as its safety and tolerability while taking AndoSanTM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm pilot nutritional study, multicentric
| Arm | Type | Receives |
|---|---|---|
| AndoSan 6 week intervention | Other | Dietary Supplement: AndoSanTMIntervention; AndoSanTM, 60 ml/day for 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Males and females from 18 to 65 years of age
- Caucasian
- Diagnosis of non-metastatic colorectal cancer (stages I-III) (documented)
- 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)
- Cancer-related fatigue present since at least 4 weeks before visit one at a stable level (self-reported)
Key exclusion criteria (11 listed)
- 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
- Severe anemia (hemoglobin (Hb) ≤ 8 g/dl within last 2 weeks before or at visit 1
- 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
- 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)
- Known HIV infection, hepatitis B or C, or active tuberculosis (self-reported)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AndoSanTMFermented water-based exctract of Agaricus subrufesence, Hericum erinacus, and Grifola frondosa | Dietary supplement | AndoSan 6 week intervention |
Primary outcome
Difference in the level of cancer-related fatigue after 6 weeks IP intake, in comparison to the baseline.
Time frame: 6 weeks
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Fatigue Subscale (FS): The FACIT-F FS is a subscale that measures the level of fatigue in patients, particularly those with chronic illnesses like cancer. The subscale consists of a set of questions scored on a scale from 0 to 52, with higher scores indicating less fatigue and therefore a better outcome. A score of 0 would indicate severe fatigue, while a score of 52 reflects minimal to no fatigue.
1 secondary outcome
Further difference in the level of cancer-related fatigue after 6 weeks IP intake, in comparison to the baseline.
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No. Data might not be shared due to intellectual property concerns.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AndoSanTM in people with Cancer-related Fatigue, run by Mycotech Pharma AS at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the level of cancer-related fatigue after 6 weeks IP intake, in comparison to the baseline. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.