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
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 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)
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
Severe anemia (hemoglobin (Hb) ≤ 8 g/dl within last 2 weeks before or at visit 1
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
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)
Single group
AndoSanTM
Dietary supplementFermented water-based exctract of Agaricus subrufesence, Hericum erinacus, and Grifola frondosa
Difference 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.
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.
The difference in the levels of inflammation markers (serum/plasma) after 3 weeks and after 6 weeks, each in comparison to the baseline.
Measurement of inflammation related parameters in blood; CRP, IL-1ß, IL-1 RA, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17A, INF-gamma, TNF-alpha. The difference in gut microbiome profiles and calprotectin levels before and after 6 weeks of IP intake.
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Mycotech Pharma AS
Lead sponsor
BioTeSys GmbH
Collaborator
