Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive of Probiotics
- Conditions
- Cancer Therapy-related Cardiovascular Toxicity
- Interventions
- Registration Number
- NCT05730777
- Lead Sponsor
- Peking University Third Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- With malignant tumors
- Will receive antitumor drugs
- Could receive regular follow-up for 6 months
- Written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment Bifidobacterium Bifidum Oral Capsule Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment Carboplatin Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment Cisplatin Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment Paclitaxel Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment Atlizumab Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment conventional antitumor treatment Cisplatin Patients in the control group will receive conventional antitumor treatment only. conventional antitumor treatment Carboplatin Patients in the control group will receive conventional antitumor treatment only. conventional antitumor treatment Paclitaxel Patients in the control group will receive conventional antitumor treatment only. conventional antitumor treatment Atlizumab Patients in the control group will receive conventional antitumor treatment only.
- Primary Outcome Measures
Name Time Method The decline rate of global longitudinal strain 6 months The primary endpoint is at least a 10% decrease in the global longitudinal strain, determined using cardiac 2D STE.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking University Third Hospital
🇨🇳Beijing, China