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

Sponsor

Peking University Third Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05728788

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Our aim in this study was to explore the correlation between early myocardial injury associated with oncology drug therapy and changes in gut microbial structure by echocardiographic two-dimensional speckle tracking technique and gut flora structure detection.

Condition or Disease	Intervention/Treatment	Phase
Cancer Therapy-related Cardiovascular Toxicity	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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhenyu Tian	Beijing		China

Sponsors and Collaborators

Peking University Third Hospital

Investigators

Principal Investigator: Ming Cui, Doctor, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking University Third Hospital

ClinicalTrials.gov Identifier:

NCT05728788

Other Study ID Numbers:

M2021598

First Posted:

Feb 15, 2023

Last Update Posted:

Feb 15, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Antineoplastic Agents

Study Results

No Results Posted as of Feb 15, 2023