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

Peking University

Status and phase: Not yet enrolling; Phase 4

Conditions: Cancer Therapy-related Cardiovascular Toxicity

Treatments: Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Bifidobacterium Bifidum Oral Capsule; Drug: Atlizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05730777

M2021485

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment

Experimental group

Description:

Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment

Treatment:

Drug: Atlizumab

Drug: Bifidobacterium Bifidum Oral Capsule

Drug: Paclitaxel

Drug: Cisplatin

Drug: Carboplatin

conventional antitumor treatment

Active Comparator group

Description:

Patients in the control group will receive conventional antitumor treatment only.

Treatment:

Drug: Atlizumab

Drug: Paclitaxel

Drug: Cisplatin

Drug: Carboplatin