Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive of Probiotics
February 15, 2023 updated by: Peking University Third Hospital
Correlation Between Early Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive and Curative Effects of Probiotics
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Beijing, China
- Peking University Third Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
|
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
Other Names:
Patients in the control group will receive conventional antitumor treatment only.
Other Names:
Patients in the control group will receive conventional antitumor treatment only.
Other Names:
Patients in the control group will receive conventional antitumor treatment only.
Other Names:
Patients in the control group will receive conventional antitumor treatment only.
Other Names:
|
|
Active Comparator: conventional antitumor treatment
Patients in the control group will receive conventional antitumor treatment only.
|
Patients in the control group will receive conventional antitumor treatment only.
Other Names:
Patients in the control group will receive conventional antitumor treatment only.
Other Names:
Patients in the control group will receive conventional antitumor treatment only.
Other Names:
Patients in the control group will receive conventional antitumor treatment only.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The decline rate of global longitudinal strain
Time Frame: 6 months
|
The primary endpoint is at least a 10% decrease in the global longitudinal strain, determined using cardiac 2D STE.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 15, 2023
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
February 6, 2023
First Submitted That Met QC Criteria
February 15, 2023
First Posted (Actual)
February 16, 2023
Study Record Updates
Last Update Posted (Actual)
February 16, 2023
Last Update Submitted That Met QC Criteria
February 15, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2021485
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.