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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
Fermented water-based exctract of Agaricus subrufesence, Hericum erinacus, and Grifola frondosa
BioTeSys GmbH
Esslingen am Neckar, Baden-Wurttemberg, Germany
RECRUITINGBioTeSys
Esslingen am Neckar, Baden-Wurttemberg, Germany
RECRUITINGanalyze & realize GmbH
Berlin, State of Berlin, Germany
RECRUITINGDifference 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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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