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Trial Title:
Mechanism Exploration of Anti-HER-2 Small-molecule Tyrosine Kinase Inhibitor-related Diarrhea and Establishment of Prevention and Treatment Model(Measure)
NCT ID:
NCT05773391
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Diarrhea
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Take probiotics
Description:
Take medication for 21 days (Yihuo 0.2g bid+ Jin Bifid2g tid)
Arm group label:
Diarrhea group
Summary:
Small-molecule tyrosine kinase inhibitors (TKI) that target HER2 are routinely used to
treat patients with HER2 (+) breast cancer. The main adverse reactions included diarrhea,
nausea, and rash, among which diarrhea had the highest incidence. It can reduce the
quality of life and medication compliance of patients, and further affect the efficacy of
TKI anti-tumor therapy. Therefore, the investigators conducted this study to establish a
risk assessment model before TKI treatment, in order to screen out the high-risk
population and influencing factors of TKI-associated diarrhea, and planned to carry out
corresponding animal experiments to verify the relationship between various mechanisms
and the main mechanism in TKI-associated diarrhea and to explore the corresponding
treatment methods.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Plan to take pyrrolidine or naratinib for ≥ 28 days;
- HER2 positive female patients with breast cancer aged ≥ 18 years and ≤ 65 years;
- Patients with the following treatment schemes: 1. Pirotinib/naratinib monotherapy 2.
Pirotinib/naratinib combined endocrine therapy; 4. The ECOG score is 0-1;
- Life expectancy ≥ 6 months;
- Patients who followed diet intervention after enrollment;
- Volunteer to join the study, sign the informed consent form, have good compliance
and are willing to cooperate with follow-up.
Exclusion Criteria:
- People who may be allergic to pyrrolidine, naratinib or excipients;
- There are many factors that affect the absorption of oral drugs, such as inability
to swallow, nausea and vomiting;
- Patients with biliary obstruction;
- Participate in other clinical trials related to diarrhea;
- Pregnant and lactating women, women with fertility and positive baseline pregnancy
test, or women of childbearing age who are unwilling to take effective contraceptive
measures during the whole trial period;
- According to the judgment of the investigator, there are concomitant diseases
(including but not limited to severe hypertension and severe diabetes beyond drug
control) that seriously endanger the patient's safety or affect the patient's
completion of the study;
- Have taken other drugs that may cause diarrhea adverse reactions within 3 weeks
before enrollment;
- There are drugs with high probability of causing diarrhea adverse reactions in
patients' combined medication;
- Any other situation in which the researcher believes that the patient is not
suitable to participate in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Xu, MD
Phone:
+86-13711277870
Email:
xufei@sysucc.org.cn
Investigator:
Last name:
Fei Xu, MD
Email:
Principal Investigator
Start date:
April 12, 2023
Completion date:
August 2024
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05773391
