Correlation Between Early Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive and Curative Effects of Probiotics
Overview
- Phase
- Phase 4
- Intervention
- Bifidobacterium Bifidum Oral Capsule
- Conditions
- Cancer Therapy-related Cardiovascular Toxicity
- Sponsor
- Peking University Third Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The decline rate of global longitudinal strain
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
Intervention: Bifidobacterium Bifidum Oral Capsule
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
Intervention: Cisplatin
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
Intervention: Carboplatin
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
Intervention: Paclitaxel
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
Intervention: Atlizumab
conventional antitumor treatment
Patients in the control group will receive conventional antitumor treatment only.
Intervention: Cisplatin
conventional antitumor treatment
Patients in the control group will receive conventional antitumor treatment only.
Intervention: Carboplatin
conventional antitumor treatment
Patients in the control group will receive conventional antitumor treatment only.
Intervention: Paclitaxel
conventional antitumor treatment
Patients in the control group will receive conventional antitumor treatment only.
Intervention: Atlizumab
Outcomes
Primary Outcomes
The decline rate of global longitudinal strain
Time Frame: 6 months
The primary endpoint is at least a 10% decrease in the global longitudinal strain, determined using cardiac 2D STE.