Correlation Between Early Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive and Curative Effects of Probiotics
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The decline rate of global longitudinal strain
研究概览
简要总结
The purpose of this study was to explore the relationship between early myocardial injury caused by tumor drug therapy and intestinal microbial structure changes by echocardiographic two-dimensional speckle tracking technique and intestinal microflora structure detection. The investigators will also explore prevention and treatment through randomized controlled trials to initiate early intervention before clinical symptoms appear.
详细描述
This is a single-center randomized controlled trial in which 100 patients treated with antineoplastic agents will be enrolled. All participants will be followed for 6 months after the initiation of oncology drug therapy. Echocardiography and 2D speckle tracking will be performed and stool and blood samples will be tested before treatment initiation and at 3 and 6 months after initiation. All patients will be randomly divided into test and control groups. Patients in the test group will receive oral Bifidobacterium trivium capsules for 6 months in addition to conventional treatment, whereas patients in the control group will receive conventional antitumor treatment only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •With malignant tumors
- •Will receive antitumor drugs
- •Could receive regular follow-up for 6 months
- •Written informed consent
排除标准
- •Satisfactory echocardiographic images could not be obtained
- •Cardiomyopathy
- •Coronary artery disease
- •Heart failure
- •Arrhythmia requiring intervention
- •Moderate or severe valvular disease
- •Acute myocarditis
- •Refractory hypertension
- •Participating in other studies of drug intervention
研究组 & 干预措施
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
干预措施: Bifidobacterium Bifidum Oral Capsule (Drug)
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
干预措施: Cisplatin (Drug)
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
干预措施: Carboplatin (Drug)
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
干预措施: Paclitaxel (Drug)
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
干预措施: Atlizumab (Drug)
conventional antitumor treatment
Patients in the control group will receive conventional antitumor treatment only.
干预措施: Cisplatin (Drug)
conventional antitumor treatment
Patients in the control group will receive conventional antitumor treatment only.
干预措施: Carboplatin (Drug)
conventional antitumor treatment
Patients in the control group will receive conventional antitumor treatment only.
干预措施: Paclitaxel (Drug)
conventional antitumor treatment
Patients in the control group will receive conventional antitumor treatment only.
干预措施: Atlizumab (Drug)
结局指标
主要结局
The decline rate of global longitudinal strain
时间窗: 6 months
The primary endpoint is at least a 10% decrease in the global longitudinal strain, determined using cardiac 2D STE.
次要结局
未报告次要终点