Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Characterization of fecal microbiome using molecular methods at baseline
研究概览
简要总结
The aim of this study is to characterize the microbiome and assess fatigue and cognition of patients with cancer undergoing standard of care treatment.
详细描述
Cancer-related fatigue is experienced by nearly all patients during treatment, and cancer-related cognitive impairment (CRCI), which is a decrease in neurocognitive functioning that can be caused by cancer or its treatment, is present in up to ¾ of patients during treatment. Fatigue and CRCI have both been linked to the composition of the gut microbiome in cancer patients. CRCI is often reported as one of the most debilitating and life-altering aspects of cancer and treatment. Although CRCI is widely reported in patients with a variety of cancers and undergoing a variety of treatments, it is not clear if the mechanisms leading to symptoms are the same throughout. Using identical methods to monitor CRCI symptoms and microbial dysbiosis in a cross-section of various cancers, cancer stages, and treatments, can help to identify commonalities associated with symptoms.
Specific Aims
Specific Aim 1: Characterize the microbiome of cancer patients and compare to healthy control subjects from previous studies.
Specific Aim 2: Assess fatigue in cancer patients and determine associations with composition of the gut microbiome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of cancer.
- •Ages 18 and over.
- •Has access to a device (smart phone, computer, tablet) with internet access.
- •Participant is willing and able to give informed consent for participation in the study.
排除标准
- •Females who are pregnant or lactating.
- •Other medical conditions or medications deemed exclusionary by the study investigators.
结局指标
主要结局
Characterization of fecal microbiome using molecular methods at baseline
时间窗: Baseline
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR at baseline
Characterization of fecal microbiome using molecular methods at 6 months
时间窗: 6 months
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR after 6 months of standard of care treatment.
次要结局
- Cognitive Function as measured by Montreal Cognitive Assessment at 6 months(6 months)
- Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at 6 months(6 months)
- Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at 6 months.(6 months)
- Cognitive Function as measured by Montreal Cognitive Assessment at baseline(Baseline)
- Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baseline(Baseline)
- Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at baseline(Baseline)