Gut Microbiota Changes in Breast Cancer Patients Treated With Abemaciclib and Correlation With Drug-Induced Diarrhea: An Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference in gut microbiota beta diversity
研究概览
简要总结
Why is this study being done? Many patients with a type of breast cancer (called HR-positive) take a medicine called Abemaciclib. While this medicine is effective, a very common side effect is diarrhea, which can be severe enough to disrupt treatment and reduce quality of life. The reason why some patients get diarrhea and others do not is not well understood. This study aims to investigate whether the natural bacteria living in the gut (known as the gut microbiome) play a role in this side effect. Researchers will compare the gut bacteria of patients who develop diarrhea with those who do not.
What will happen in the study? This is an observational study, which means that patients will receive their normal cancer treatment and will not be given any new or experimental drugs as part of this initial phase.
- Patients who are already being treated with Abemaciclib will be invited to join.
- They will be placed into one of two groups: those who experience diarrhea and those who do not.
- Participants will be asked to provide stool (feces) samples and may also provide optional blood samples at specific times during their treatment.
- Researchers will analyze these samples in the lab to study the types and functions of the gut bacteria.
Who can participate?
- Adult women (aged 18-75) diagnosed with HR-positive breast cancer.
- Currently receiving treatment with Abemaciclib for at least 2 weeks.
- Must be willing to provide informed consent and follow the study procedures.
What are the potential benefits? Participants will not receive any direct medical benefit from taking part in this study. However, the information learned may help researchers better understand why diarrhea occurs and, in the future, could lead to new ways to prevent or treat this side effect for other cancer patients.
How is privacy protected? All personal information and samples collected will be de-identified using a unique code. This means that the data used for analysis cannot be directly linked back to the participant's identity. All data is stored securely according to strict ethical guidelines.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75 years.
- •Diagnosed with hormone receptor-positive (HR⁺) breast cancer.
- •Currently receiving treatment with Abemaciclib (either as monotherapy or in combination with endocrine therapy) for a duration of at least 2 weeks.
- •Willing and able to provide written informed consent for participation in the study.
排除标准
- •History of major gastrointestinal diseases, such as inflammatory bowel disease, Crohn's disease, ulcerative colitis, or intestinal obstruction, or having undergone major gastrointestinal surgery.
- •Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine that may alter gut function.
- •Pregnant or lactating women.
- •Unwilling to provide informed consent or considered by the investigator to be unsuitable for the study for any other reason.
结局指标
主要结局
Difference in gut microbiota beta diversity
时间窗: Through study completion, an average of 6 months.
Beta diversity of the gut microbiome (e.g., Weighted UniFrac distance) will be compared between the diarrhea group and the non-diarrhea group to assess overall microbial community structure differences.
Identification of specific bacterial species enriched in non-diarrhea group
时间窗: Through study completion, an average of 6 months.
Metagenomic sequencing data will be analyzed (e.g., using LEfSe) to identify bacterial species that are significantly enriched in the non-diarrhea group compared to the diarrhea group (LDA Score \> 2, p-value \< 0.05).
次要结局
- Difference in metagenomic functional pathways(Through study completion, an average of 6 months.)
- Difference in gut microbiota alpha diversity(Through study completion, an average of 6 months.)
- Differential metabolites in serum(Through study completion, an average of 6 months.)
- Difference in systemic inflammatory cytokine levels(Through study completion, an average of 6 months.)
研究者
Xinhong Wu, PhD
vice-president
Hubei Cancer Hospital