A Phase 4 interventional study of Bifidobacterium Bifidum Oral Capsule and Cisplatin in Cancer Therapy-related Cardiovascular Toxicity, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-16.
Sponsored by Peking University Third Hospital · Phase 4, Interventional, and Treatment
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.
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.
Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
Drug: Bifidobacterium Bifidum Oral Capsule · Drug: Cisplatin · Drug: Carboplatin · Drug: Paclitaxel · Drug: Atlizumab
Patients in the control group will receive conventional antitumor treatment only.
Drug: Cisplatin · Drug: Carboplatin · Drug: Paclitaxel · Drug: Atlizumab
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
Also known as: Probiotics
Patients in the control group will receive conventional antitumor treatment only.
Also known as: conventional antitumor treatmen
Patients in the control group will receive conventional antitumor treatment only.
Also known as: conventional antitumor treatmen
Patients in the control group will receive conventional antitumor treatment only.
Also known as: conventional antitumor treatmen
Patients in the control group will receive conventional antitumor treatment only.
Also known as: conventional antitumor treatmen
The decline rate of global longitudinal strain
The primary endpoint is at least a 10% decrease in the global longitudinal strain, determined using cardiac 2D STE.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital