Cancer Therapy-related Cardiovascular Toxicity
Conditions
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.
Interventions
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
DRUGCisplatin
Patients in the control group will receive conventional antitumor treatment only.
DRUGCarboplatin
Patients in the control group will receive conventional antitumor treatment only.
DRUGPaclitaxel
Patients in the control group will receive conventional antitumor treatment only.
DRUGAtlizumab
Patients in the control group will receive conventional antitumor treatment only.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactZhenyu Tian, Doctor
Outcome results
None listed