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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment | Experimental | Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment |
|
| conventional antitumor treatment | Active Comparator | Patients in the control group will receive conventional antitumor treatment only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifidobacterium Bifidum Oral Capsule | Drug | Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenyu Tian, Doctor | Contact | +8613051871220 | tzy003@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ming Cui, Doctor | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | China |
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|
| Cisplatin | Drug | Patients in the control group will receive conventional antitumor treatment only. |
|
|
| Carboplatin | Drug | Patients in the control group will receive conventional antitumor treatment only. |
|
|
| Paclitaxel | Drug | Patients in the control group will receive conventional antitumor treatment only. |
|
|
| Atlizumab | Drug | Patients in the control group will receive conventional antitumor treatment only. |
|
|
| ID | Term |
|---|---|
| D019936 | Probiotics |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| C502936 | tocilizumab |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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