Pilot Study to Evaluate the Effects of a Food Product Containing Mushroom Extracts (AndoSanTM) in Subjects with Colorectal Cancer-related Fatigue

Recruitment & Eligibility

Status: RECRUITING

Sex: All

Target Recruitment: 30

Inclusion Criteria

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 prior to visit 1, both assessed at visit 1)
Cancer-related fatigue present since at least 4 weeks before visit 1 at a stable level (self-reported)
Cancer treatment completed (as reported by the attending physician prior to study) considering 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)
Serum C-reactive protein (CRP) levels > 3 mg/l at visit1/ Screening
Stable medication for comorbidities (if any)
Established cancer-related fatigue management regime in line with current guidelines, if any, since at least 4 weeks (e.g., physical exercise counselling, medication/supplementation, nutritional counselling, psychosocial counselling)
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
Negative pregnancy test at V1 and willingness to use a reliable method of contraception during the study in women of childbearing potential
Readiness and ability to understand and comply with study requirements as judged by the investigator (to take the IP as recommended)

Exclusion Criteria

Rapidly progressing cancer without reasonable treatment options and/or serious worsening of cancer disease during the study as well as the need of 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 prior to or at visit 1
Acute illness or uncontrolled chronic metabolic illness (including diabetes mellitus, hyperthyroidism, hypothyroidism and excluding adequately medicated hypothyroidism), uncontrolled pain, 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 judgement
Psychiatric disorders, including recently occurred (within last 12 weeks prior to visit 1) or severe depression as judged by the investigator (stable treatment with low-dose selective serotonin reuptake inhibitors (SSRIs) is permitted)
Known HIV infection, hepatitis B or C, or active tuberculosis (self-reported)
Major surgery within 4 weeks before study or planned surgery during the treatment period
Consuming any other food supplements / FSMPs during the study such as, e.g. ginseng, guarana, mistletoe
History of or current abuse of medication, e.g. opioids, drugs, or alcohol
Participation in another study during the last 30 days prior to and during the study
Breast feeding
Any other reason for exclusion as per 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)

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AndoSan 6 week intervention	AndoSanTM	Intervention; AndoSanTM, 60 ml/day for 6 weeks

Primary Outcome Measures

Name	Time	Method
Difference in the level of cancer-related fatigue after 6 weeks IP intake, in comparison to the baseline.	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Further difference in the level of cancer-related fatigue after 6 weeks IP intake, in comparison to the baseline.	6 weeks	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.

Pilot Study to Evaluate the Effects of a Food Product Containing Mushroom Extracts (AndoSanTM) in Subjects with Colorectal Cancer-related Fatigue

Recruitment & Eligibility

Study & Design

Trial Locations

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