Trial Title:
The Effects of a Food Product Containing Mushroom Extracts (AndoSanTM) in Subjects with Colorectal Cancer-related Fatigue
NCT ID:
NCT06599710
Condition:
Cancer-related Fatigue
Conditions: Official terms:
Colorectal Neoplasms
Fatigue
Conditions: Keywords:
Cancer-related fatigue
Colorectal cancer
Andosan
Agaricus blazei Murill
Hericium erinaceus
Agaricus subrufesence
Mushroom extract
Grifola frondosa
Chronic inflammation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single-arm pilot nutritional study, multicentric
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
AndoSanTM
Description:
Fermented water-based exctract of Agaricus subrufesence, Hericum erinacus, and Grifola
frondosa
Arm group label:
AndoSan 6 week intervention
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 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.
Criteria for eligibility:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
BioTeSys GmbH
Address:
City:
Esslingen
Zip:
73728
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christiane Schoen
Phone:
+49 711 31057145
Email:
c.schoen@biotesys.de
Contact backup:
Last name:
Tanita Dharsono
Phone:
+49 711 31057136
Email:
t.dharsono@biotesys.de
Contact backup:
Last name:
Daniel Menzel, MD
Facility:
Name:
BioTeSys
Address:
City:
Esslingen
Zip:
73728
Country:
Germany
Status:
Recruiting
Facility:
Name:
analyze & realize GmbH
Address:
City:
Berlin
Zip:
10369
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Natalie Doberstein
Phone:
+49 3040008156
Email:
ndoberstein@a-r.com
Contact backup:
Last name:
Anh Duyen Hoang Nguyen
Phone:
+49 3040008406
Email:
anguyen@a-r.com
Contact backup:
Last name:
Liana Vismane
Start date:
September 9, 2024
Completion date:
February 2025
Lead sponsor:
Agency:
Mycotech Pharma AS
Agency class:
Industry
Collaborator:
Agency:
BioTeSys GmbH
Agency class:
Other
Source:
Mycotech Pharma AS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06599710
