NCT05730777

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer Therapy-related Cardiovascular Toxicity

Interventions

Type	Name	Description
DRUG	Bifidobacterium Bifidum Oral Capsule	Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
DRUG	Cisplatin	Patients in the control group will receive conventional antitumor treatment only.
DRUG	Carboplatin	Patients in the control group will receive conventional antitumor treatment only.
DRUG	Paclitaxel	Patients in the control group will receive conventional antitumor treatment only.
DRUG	Atlizumab	Patients in the control group will receive conventional antitumor treatment only.

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-07-01
• Completion: 2023-12-31
• First posted: 2023-02-16
• Last updated: 2023-02-16

Locations

1 site across 1 country: China