Effects of mushroom extract on fatigue in colorectal cancer patients
Pilot Study to Evaluate the Effects of a Food Product Containing Mushroom Extracts (AndosanTM) in Subjects with Colorectal Cancer-Related Fatigue
This study is testing if a mushroom extract drink can help reduce fatigue in people with non-metastatic colorectal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Mycotech Pharma AS Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Esslingen am Neckar, Baden-Wurttemberg and 2 other locations) |
| Trial ID | NCT06599710 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effects of a specialized liquid food product, AndoSanTM, which contains fermented extracts from various mushrooms, on cancer-related fatigue in individuals with non-metastatic colorectal cancer. The primary objective is to assess changes in fatigue levels among participants, while secondary objectives include evaluating health-related quality of life, inflammation markers, and the safety and tolerability of AndoSanTM. Participants will be monitored for their fatigue symptoms and overall health status throughout the study.
Who should consider this trial
Good fit: Ideal candidates are Caucasian males and females aged 18 to 65 with a diagnosis of non-metastatic colorectal cancer and persistent moderate to severe cancer-related fatigue.
Not a fit: Patients with metastatic colorectal cancer or those currently undergoing cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce fatigue and improve quality of life for patients suffering from colorectal cancer-related fatigue.
How similar studies have performed: While the use of mushroom extracts for health benefits is gaining interest, this specific approach targeting colorectal cancer-related fatigue is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Esslingen am Neckar, Baden-Wurttemberg and 2 other locations
- BioTeSys GmbH — Esslingen am Neckar, Baden-Wurttemberg, Germany (Recruiting)
- BioTeSys — Esslingen am Neckar, Baden-Wurttemberg, Germany (Recruiting)
- analyze & realize GmbH — Berlin, State of Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Daniel Menzel
- Email: d.menzel@biotesys.de
- Phone: +49 71131057150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.