Associations of Fatigue and Chemotherapy-Induced Nausea With Changes in Gut Microbiome Composition Profiles
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- Number of patients approached
研究概览
简要总结
This pilot study seeks to understand how changes in the bacteria composition (microbiome) of the gut may be associated with the occurrence of fatigue and chemotherapy-induced nausea (CIN) in women undergoing chemotherapy for early stage breast cancer. Patients undergoing chemotherapy may experience fatigue or nausea as a result of their treatment. Known risk factors for fatigue and CIN do not explain the differences in fatigue and CIN occurrence between patients, but changes in the functions of the gut microbiome may be related to the occurrence of fatigue and CIN. This study collects stool samples from breast cancer patients before and after chemotherapy to evaluate how changes in the microbiome may be associated with fatigue and CIN.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of patient recruitment and retention, as well as specimen collection.
II. Estimate the effect size for changes in gut microbiome composition profiles and metabolites in stool as well as blood from time of first stool sample collection prior to chemotherapy (T1) to time of second stool sample collection after chemotherapy (T2) that are associated with the occurrence of fatigue and CIN.
III. Evaluate associations between patient reported demographic and clinical characteristics, comorbidities at T1, and changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 with the occurrence of fatigue and CIN.
OUTLINE: This is an observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a diagnosis of early stage breast cancer planning to receive moderate to highly emetogenic chemotherapy will be recruited at Mayo Clinic Health Systems including Mankato and Albert Lea; Mayo Clinic Arizona; Mayo Clinic Rochester (Minnesota); and Mayo Clinic Florida
- •At least 20 years of age
- •Last chemotherapy more than 3 years ago
- •Scheduled to receive moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies
排除标准
- •Metastatic disease
- •Concurrent radiation therapy
- •Concurrent antibiotic treatment
结局指标
主要结局
Number of patients approached
时间窗: Up to 24 months
Assessed using descriptive statistics.
Number of patients enrolled
时间窗: Up to 24 months
Assessed using descriptive statistics.
Number of patients who completed the questionnaires at both assessments
时间窗: At baseline and 3-5 days after initiation of chemotherapy
Assessed using descriptive statistics.
Number of patients who provided stool samples at both assessments
时间窗: At baseline and 3-5 days after initiation of chemotherapy
Assessed using descriptive statistics.
Bacterial composition of stool samples
时间窗: Up to study completion
All stool samples will be processed for deoxyribonucleic acid extraction. The hypervariable regions V3 and V4 of the bacterial 16S ribosomal ribonucleic acid (rRNA) gene will be sequenced to determine bacterial composition. After quality control, 16S rRNA reads will be analyzed to determine operational taxonomic units (OTU) for T1 and T2 samples using QIIME software. Alpha (within sample) diversity and beta (between sample) diversity will be analyzed using nonmetric multidimensional scaling ordination and the effect size for changes in OTUs in gut microbiome composition profiles from T1 to T2 in patients who do and do not report fatigue or chemotherapy-induced nausea (CIN) at T2 as measured by questionnaire.
Differences in demographic between patients who do and do not report fatigue and CIN
时间窗: Up to study completion
Evaluated using parametric and non-parametric tests. The changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 associated with the occurrence of fatigue and CIN will be evaluated.
Differences in clinical characteristics between patients who do and do not report CIN
时间窗: Up to study completion
Evaluated using parametric and non-parametric tests. The changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 associated with the occurrence of CIN will be evaluated.
Differences in comorbidities between patients who do and do not report CIN
时间窗: Up to study completion
Evaluated using parametric and non-parametric tests. The changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 associated with the occurrence of CIN will be evaluated.
次要结局
未报告次要终点