Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women With Breast Cancer Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Symptom burden - MSAS
研究概览
简要总结
This study evaluates the relationship between alterations in the GI microbiome and GI inflammation on symptom burden in women with breast cancer receiving chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I. To describe changes in GI inflammation and the GI microbiome profile in women with breast cancer throughout chemotherapy.
II. To examine how GI inflammation and GI microbiome changes influence symptom experience is used above in women with breast cancer receiving chemotherapy.
III. To examine associations between microbial composition functional profiles at T1 and T2, T3 as well as T4 in patients who report symptom severity in neuropsychological and GI symptoms at the last three timepoints.
IV. To evaluate for differentially abundant metabolites and perturbed metabolic pathways associated with microbiome diversity in patients who do and do not report neuropsychological and GI symptom occurrence at T2, T3 and T4.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female with a new diagnosis of breast cancer (stage I-III)
- •Age 20 or older
- •Able to read and write in English
- •Chemotherapy naive and beginning the first cycle of moderately or highly emetogenic chemotherapy (For example, Taxotere + cyclophosphamide treatment +/- trastuzumab). Patients who have not received chemotherapy for five years or more are considered chemotherapy naive
排除标准
- •Metastatic disease
- •Cognitive impairment, based on clinician assessment, that would prevent completing measures
- •Concurrent radiation therapy or radiation therapy within the last three months
- •GI co-morbidities (i.e., irritable bowel syndrome, gastroesophageal reflux disease) or bowel surgery within the last three months
- •A stoma preventing stool collection from the large intestine (i.e., ileostomy)
结局指标
主要结局
Symptom burden - MSAS
时间窗: Up to 1 month after chemotherapy treatment completion
Symptom burden will be measured with a modified version of the Memorial Symptom Assessment Scale (MSAS). The modified MSAS includes 41 symptom items, including 19 GI symptoms. Participants are asked to review the list of symptoms and indicate which had been present in the last week. For each symptom present, participants are asked to rate its duration, severity, and distress.
Change in GI inflammation
时间窗: Up to 1 month after chemotherapy treatment completion
GI Inflammation will be quantified through measures of fecal calprotectin to indicate low, medium and high concentrations of bowel inflammation.
Change in GI microbiome profile
时间窗: Up to 1 month after chemotherapy treatment completion
To examine longitudinal change in the GI microbiome, the coefficient of variation (CV) of alpha-diversity values will be calculated for stool samples. The CV represents the ratio of the standard deviation to the mean. A low CV indicates that an individual has relatively stable microbial diversity over time and a high CV indicates that an individual has higher microbial diversity over time.
Symptom burden - MASCC-MAT
时间窗: Up to 1 month after chemotherapy treatment completion
Symptom burden will be measured with the Multinational Association of Supportive Care in Cancer-Antiemesis Tool (MASCC-MAT). The MASCC-MAT assesses acute (i.e., within 24 hours post-chemotherapy) and delayed (i.e., after 24 hours and up to 7 days post-chemotherapy) occurrence of chemotherapy-induced nausea (CIN).
Symptom burden - LFS
时间窗: Up to 1 month after chemotherapy treatment completion
Symptom burden will be measured with the Lee Fatigue Scale (LFS). The LFS consists of 18 items related to fatigue and energy. Scores range from 0-180 with higher scores indicating higher levels of fatigue.
次要结局
- Associations between microbial composition functional profiles and symptom severity(Up to 1 month after chemotherapy treatment completion)
- Change in metabolite abundance(Up to 1 month after chemotherapy treatment completion)