The Effects of a Food Product Containing Mushroom Extracts (AndoSanTM) in Subjects with Colorectal Cancer-related Fatigue

NCT06599710 | Recruiting

• 1 other identifier: BTS2088/24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Cancer-related Fatigue

Keywords

Cancer-related fatigue; Colorectal cancer; Andosan; Agaricus blazei Murill; Hericium erinaceus; Agaricus subrufesence; Mushroom extract; Grifola frondosa; Chronic inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (1)

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

  6 weeks

Other Outcomes (1)

• The difference in the levels of inflammation markers (serum/plasma) after 3 weeks and after 6 weeks, each in comparison to the baseline.

  6 weeks

Study Arms (1)

AndoSan 6 week intervention

OTHER

Intervention; AndoSanTM, 60 ml/day for 6 weeks

Dietary Supplement: AndoSanTM

Interventions

AndoSanTM DIETARY_SUPPLEMENT

Fermented water-based exctract of Agaricus subrufesence, Hericum erinacus, and Grifola frondosa

AndoSan 6 week intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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 greater than 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 counseling, medication/supplementation, nutritional counseling, psychosocial counseling)
• 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)

You may not qualify if:

• 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
• Participation in another study during the last 30 days before and during the study
• Breastfeeding

Sponsors & Collaborators

• Mycotech Pharma AS: lead
• BioTeSys GmbH: collaborator

Study Sites (3)

BioTeSys GmbH

Esslingen am Neckar, Baden-Wurttemberg, 73728, Germany

RECRUITING

BioTeSys

Esslingen am Neckar, Baden-Wurttemberg, 73728, Germany

RECRUITING

analyze & realize GmbH

Berlin, State of Berlin, 10369, Germany

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Daniel Menzel

CONTACT

+49 71131057150; d.menzel@biotesys.de

Tanita Dharsono

CONTACT

+49 711 31057136; t.dharsono@biotesys.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm pilot nutritional study, multicentric

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: September 9, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)