Actively Recruiting
Pilot Study to Evaluate 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
N/A
Total Duration
On this page
Sponsors
M
Mycotech Pharma AS
Lead Sponsor
B
BioTeSys GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a specialized liquid food product called AndoSanTM, which contains fermented extracts from mushrooms Agaricus subrufesence, Hericium erinaceus, and Grifola frondosa, in people experiencing colorectal cancer-related fatigue. This pilot study aims to assess changes in cancer-related fatigue complaints, health-related quality of life, inflammation markers, safety, and tolerability while taking AndoSanTM. Participants will take 60 ml of AndoSanTM daily for 6 weeks. The study focuses on observing changes in cancer-related fatigue compared to baseline levels. There is no placebo or comparator group mentioned, and the treatment involves only the mushroom extract product during this period. During the 6-week intervention, participants will be monitored for changes in fatigue levels using validated scales and assessments. Researchers will also evaluate quality of life and inflammation markers. Safety and tolerability will be assessed throughout the study. The primary outcome is the difference in cancer-related fatigue after 6 weeks compared to the start of the study.
CONDITIONS
Brief 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 ethnicity
- Documented diagnosis of non-metastatic colorectal cancer (stages I-III)
- Persistent moderate or severe cancer-related fatigue (NRS score 24 4 and FACIT-F FS score 24 34) assessed at first visit
- Fatigue present at a stable level for at least 4 weeks before first visit
- Completed cancer treatment: at least 4 weeks since last therapy and 6 weeks since surgery
- Serum C-reactive protein (CRP) levels greater than 3 mg/l at screening
- Stable medication for any other health conditions
- Established cancer-related fatigue management following guidelines for at least 4 weeks
- Expected to maintain usual activity level and dietary habits during the study
- Negative pregnancy test at first visit and willingness to use reliable contraception for women of childbearing potential
- Ability and readiness to understand and comply with study requirements
You will not qualify if you...
- Rapidly progressing cancer or serious worsening needing treatment changes during study
- Severe anemia (hemoglobin 24 8 g/dl) within 2 weeks before or at first visit
- Acute illness or uncontrolled chronic metabolic diseases causing fatigue
- Psychiatric disorders including recent or severe depression
- Known HIV, hepatitis B or C, or active tuberculosis
- Major surgery within 4 weeks before study or planned during treatment
- Use of other food supplements such as ginseng, guarana, or mistletoe during study
- History or current abuse of medication, drugs, or alcohol
- Participation in another study within 30 days before or during this study
- Breastfeeding
- Any other exclusion judged by the investigator such as allergy to the study product or poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants take AndoSanTM, a food product containing mushroom extracts, daily and are monitored for changes in cancer-related fatigue and quality of life.
Regular visits during treatment as scheduled by the study team
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
T
Tanita Dharsono
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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