Actively Recruiting
The Effects of a Food Product Containing Mushroom Extracts (AndoSanTM) in Subjects with Colorectal Cancer-related Fatigue
Led by Mycotech Pharma AS · Updated on 2024-09-20
30
Participants Needed
3
Research Sites
20 weeks
Total Duration
On this page
Sponsors
M
Mycotech Pharma AS
Lead Sponsor
B
BioTeSys GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
The Effects of a Food Product Containing Mushroom Extracts (AndoSanTM) in Subjects with Colorectal Cancer-related Fatigue
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 (≥ 4 on 0-10 Numerical Rating Scale and FACIT-F Fatigue subscale score ≤ 34)
- Cancer-related fatigue present for at least 4 weeks at a stable level
- Cancer treatment completed at least 4 weeks after last therapy and 6 weeks after surgery
- Serum C-reactive protein (CRP) levels greater than 3 mg/l at screening
- Stable medication for comorbidities, if any
- Established cancer-related fatigue management regime for at least 4 weeks
- Expected to maintain usual activity and dietary habits during the study
- Negative pregnancy test at visit 1 and willingness to use reliable contraception for women of childbearing potential
- Ability to understand and comply with study requirements as judged by investigator
You will not qualify if you...
- Rapidly progressing cancer without treatment options or serious worsening during the study
- Severe anemia (hemoglobin ≤ 8 g/dl within 2 weeks before or at visit 1)
- Acute illness or uncontrolled chronic metabolic illness (including diabetes, thyroid disorders except medicated hypothyroidism), uncontrolled pain, or other disorders causing fatigue
- Psychiatric disorders including recent or severe depression (stable low-dose SSRI treatment allowed)
- Known HIV infection, hepatitis B or C, or active tuberculosis
- Major surgery within 4 weeks before study or planned surgery during treatment
- Use of other food supplements or FSMPs during the study
- History or current abuse of medications, drugs, or alcohol
- Participation in another study within 30 days before or during this study
- Breastfeeding
- Other reasons judged by investigator such as hypersensitivity to the investigational product or expected poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
BioTeSys GmbH
Esslingen am Neckar, Baden-Wurttemberg, Germany, 73728
Actively Recruiting
2
BioTeSys
Esslingen am Neckar, Baden-Wurttemberg, Germany, 73728
Actively Recruiting
3
analyze & realize GmbH
Berlin, State of Berlin, Germany, 10369
Actively Recruiting
Research Team
D
Daniel Menzel
CONTACT
T
Tanita Dharsono
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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