Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy

Correlation Between Early Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Therapy-related Cardiovascular Toxicity
• Intervention / Treatment: Drug: Antitumor drugs

Detailed Description

This is a monocentric prospective cohort study in which 50 patients treated for malignant tumors will be included. 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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Zhenyu Tian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with antineoplastic agents

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated with antineoplastic agents; 50 patients treated with antineoplastic agents will be enrolled.	Drug: Antitumor drugs; Anthracyclines, immune checkpoint inhibitors, monoclonal antibodies, and tyrosine kinase inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
At least a 10% decrease in the global longitudinal strain	The primary endpoint is at least a 10% decrease in the global longitudinal strain, determined using cardiac 2D STE and compared with baseline.	6 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents
• Other Study ID Numbers: M2021598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No