Cancer Therapy-related Cardiovascular ToxicityPhase 4NCT05730777
Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive of Probiotics
A Phase 4 study testing Bifidobacterium Bifidum Oral Capsule, Cisplatin and Carboplatin in people with Cancer Therapy-related Cardiovascular Toxicity, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer Therapy-related Cardiovascular Toxicity
- What is being tested?
- Bifidobacterium Bifidum Oral Capsule, Cisplatin and Carboplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2023to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With malignant tumors
- Will receive antitumor drugs
- Could receive regular follow-up for 6 months
- Written informed consent
Who cannot join
- Satisfactory echocardiographic images could not be obtained
- Cardiomyopathy
- Coronary artery disease
- Heart failure
- Arrhythmia requiring intervention
- Moderate or severe valvular disease
Show all 9Show fewer
- Acute myocarditis
- Refractory hypertension
- Participating in other studies of drug intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Bifidobacterium Bifidum Oral Capsule, Cisplatin, Carboplatin, Paclitaxel, Atlizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium Bifidum Oral CapsuleDrug
Also called Probiotics
Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment
CisplatinDrug
Also called conventional antitumor treatmen
Patients in the control group will receive conventional antitumor treatment only.
CarboplatinDrug
Also called conventional antitumor treatmen
Patients in the control group will receive conventional antitumor treatment only.
PaclitaxelDrug
Also called conventional antitumor treatmen
Patients in the control group will receive conventional antitumor treatment only.
AtlizumabDrug
Also called conventional antitumor treatmen
Patients in the control group will receive conventional antitumor treatment only.
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment | Experimental | Bifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment Receives: Drug: Bifidobacterium Bifidum Oral Capsule; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Atlizumab |
| conventional antitumor treatment | Active comparator | Patients in the control group will receive conventional antitumor treatment only. Receives: Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Atlizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Therapy-related Cardiovascular ToxicityStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Cui, Doctor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730777
- Sponsor's protocol ID
- M2021485
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Early Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive and Curative Effects of Probiotics
- ClinicalTrials.gov ID
- NCT05730777
- Acronym / sponsor ID
- M2021485
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment | Experimental | Drug: Bifidobacterium Bifidum Oral Capsule, Drug: Cisplatin, Drug: Carboplatin, Drug: Paclitaxel, Drug: AtlizumabBifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment |
| conventional antitumor treatment | Active comparator | Drug: Cisplatin, Drug: Carboplatin, Drug: Paclitaxel, Drug: AtlizumabPatients in the control group will receive conventional antitumor treatment only. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- With malignant tumors
- Will receive antitumor drugs
- Could receive regular follow-up for 6 months
- Written informed consent
Key exclusion criteria (9 listed)
- Satisfactory echocardiographic images could not be obtained
- Cardiomyopathy
- Coronary artery disease
- Heart failure
- Arrhythmia requiring intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium Bifidum Oral CapsuleAlso: ProbioticsBifidobacterium Bifidum Oral Capsule for 6 months in addition to conventional treatment | Drug | Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment |
| CisplatinAlso: conventional antitumor treatmenPatients in the control group will receive conventional antitumor treatment only. | Drug | Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment, conventional antitumor treatment |
| CarboplatinAlso: conventional antitumor treatmenPatients in the control group will receive conventional antitumor treatment only. | Drug | Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment, conventional antitumor treatment |
| PaclitaxelAlso: conventional antitumor treatmenPatients in the control group will receive conventional antitumor treatment only. | Drug | Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment, conventional antitumor treatment |
| AtlizumabAlso: conventional antitumor treatmenPatients in the control group will receive conventional antitumor treatment only. | Drug | Bifidobacterium Bifidum Oral Capsule in addition to conventional treatment, conventional antitumor treatment |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Cui, Doctor principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bifidobacterium Bifidum Oral Capsule, Cisplatin and Carboplatin in people with Cancer Therapy-related Cardiovascular Toxicity, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenyu Tian, Doctor (+8613051871220, tzy003@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The decline rate of global longitudinal strain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.