Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive of Probiotics

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Correlation Between Early Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive and Curative Effects of Probiotics

Conditions
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Cancer Therapy-related Cardiovascular Toxicity

Intervention / Treatment
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* Drug: Bifidobacterium Bifidum Oral Capsule
* Drug: Cisplatin
* Drug: Carboplatin
* Drug: Paclitaxel
* Drug: Atlizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With malignant tumors Will receive antitumor drugs Could receive regular follow-up for 6 months Written informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment<br>Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment | Drug: Bifidobacterium Bifidum Oral Capsule<br>* Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment<br>* Other names: Probiotics;Drug: Cisplatin<br>* Patients in the control group will receive conventional antitumor treatment only.<br>* Other names: conventional antitumor treatmen;Drug: Carboplatin<br>* Patients in the control group will receive conventional antitumor treatment only.<br>* Other names: conventional antitumor treatmen;Drug: Paclitaxel<br>* Patients in the control group will receive conventional antitumor treatment only.<br>* Other names: conventional antitumor treatmen;Drug: Atlizumab<br>* Patients in the control group will receive conventional antitumor treatment only.<br>* Other names: conventional antitumor treatmen;|
| Active Comparator: conventional antitumor treatment<br>Patients in the control group will receive conventional antitumor treatment only. | Drug: Cisplatin<br>* Patients in the control group will receive conventional antitumor treatment only.<br>* Other names: conventional antitumor treatmen;Drug: Carboplatin<br>* Patients in the control group will receive conventional antitumor treatment only.<br>* Other names: conventional antitumor treatmen;Drug: Paclitaxel<br>* Patients in the control group will receive conventional antitumor treatment only.<br>* Other names: conventional antitumor treatmen;Drug: Atlizumab<br>* Patients in the control group will receive conventional antitumor treatment only.<br>* Other names: conventional antitumor treatmen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decline rate of global longitudinal strain | The primary endpoint is at least a 10% decrease in the global longitudinal strain, determined using cardiac 2D STE. | 6 months |