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Trial Title:
Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive of Probiotics
NCT ID:
NCT05730777
Condition:
Cancer Therapy-related Cardiovascular Toxicity
Conditions: Official terms:
Paclitaxel
Carboplatin
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Bifidobacterium Bifidum Oral Capsule
Description:
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
Arm group label:
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Other name:
Probiotics
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Patients in the control group will receive conventional antitumor treatment only.
Arm group label:
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Arm group label:
conventional antitumor treatment
Other name:
conventional antitumor treatmen
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Patients in the control group will receive conventional antitumor treatment only.
Arm group label:
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Arm group label:
conventional antitumor treatment
Other name:
conventional antitumor treatmen
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Patients in the control group will receive conventional antitumor treatment only.
Arm group label:
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Arm group label:
conventional antitumor treatment
Other name:
conventional antitumor treatmen
Intervention type:
Drug
Intervention name:
Atlizumab
Description:
Patients in the control group will receive conventional antitumor treatment only.
Arm group label:
Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment
Arm group label:
conventional antitumor treatment
Other name:
conventional antitumor treatmen
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Country:
China
Start date:
February 15, 2023
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05730777
