Pilot Study to Evaluate the Effects of a Food Product Containing Mushroom Extracts (AndosanTM) in Subjects With Colorectal Cancer-Related Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Difference in the level of cancer-related fatigue after 6 weeks IP intake, in comparison to the baseline.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females from 18 to 65 years of age
- •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)
排除标准
- •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
- •Any other reason for exclusion as per the 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)
研究组 & 干预措施
AndoSan 6 week intervention
Intervention; AndoSanTM, 60 ml/day for 6 weeks
干预措施: AndoSanTM (Dietary Supplement)
结局指标
主要结局
Difference in the level of cancer-related fatigue after 6 weeks IP intake, in comparison to the baseline.
时间窗: 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.
次要结局
- Further difference in the level of cancer-related fatigue after 6 weeks IP intake, in comparison to the baseline.(6 weeks)