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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05730777
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
10.5
Anticipated Duration (Months)
19.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Correlation Between Early Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive and Curative Effects of Probiotics
Anticipated Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Drug: Bifidobacterium Bifidum Oral Capsule
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
Other Names:
  • Probiotics

    • Drug: Cisplatin
    Patients in the control group will receive conventional antitumor treatment only.
    Other Names:
  • conventional antitumor treatmen

    • Drug: Carboplatin
    Patients in the control group will receive conventional antitumor treatment only.
    Other Names:
  • conventional antitumor treatmen

    • Drug: Paclitaxel
    Patients in the control group will receive conventional antitumor treatment only.
    Other Names:
  • conventional antitumor treatmen

    • Drug: Atlizumab
    Patients in the control group will receive conventional antitumor treatment only.
    Other Names:
  • conventional antitumor treatmen

    		•
    Active Comparator: conventional antitumor treatment

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

    Drug: Cisplatin
    Patients in the control group will receive conventional antitumor treatment only.
    Other Names:
  • conventional antitumor treatmen

    • Drug: Carboplatin
    Patients in the control group will receive conventional antitumor treatment only.
    Other Names:
  • conventional antitumor treatmen

    • Drug: Paclitaxel
    Patients in the control group will receive conventional antitumor treatment only.
    Other Names:
  • conventional antitumor treatmen

    • Drug: Atlizumab
    Patients in the control group will receive conventional antitumor treatment only.
    Other Names:
  • conventional antitumor treatmen

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The decline rate of global longitudinal strain [6 months]

      The primary endpoint is at least a 10% decrease in the global longitudinal strain, determined using cardiac 2D STE.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 Peking University Third Hospital 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:
    NCT05730777
    Other Study ID Numbers:
    • M2021485
    First Posted:
    Feb 16, 2023
    Last Update Posted:
    Feb 16, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Paclitaxel
    Cisplatin
    Carboplatin

    Study Results

    No Results Posted as of Feb 16, 2023