The Effects of a Food Product Containing Mushroom Extracts (AndoSanTM) in Subjects With Colorecta… (NCT06599710) | Clinical Trial Compass
WithdrawnNot Applicable
The Effects of a Food Product Containing Mushroom Extracts (AndoSanTM) in Subjects With Colorectal Cancer-related Fatigue
Stopped: Insufficient recruitment
Germany0Started 2024-09-09
Plain-language 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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 before visit 1, both assessed at visit 1)
. Cancer-related fatigue present since at least 4 weeks before visit one at a stable level (self-reported)
. Cancer treatment completed (as reported by the attending physician before the study) considering the following conditions:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in the level of cancer-related fatigue after 6 weeks IP intake, in comparison to the baseline.
. Serum C-reactive protein (CRP) levels greater than 3 mg/l at visit1/ Screening
. Stable medication for comorbidities (if any)
Exclusion criteria
. 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)
. 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, e.g. ginseng, guarana, mistletoe
. History of or current abuse of medication, e.g. opioids, drugs, or alcohol