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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diarrhea group | Experimental | Patients with diarrhea after taking pyrrolidine/naratinib,implement intervention (Yihuo 0.2g po bid+ Gold bifidum 2g po tid) |
|
| No diarrhea group | No Intervention | Patients without diarrhea after taking pyrrolidine/naratinib |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Take probiotics | Drug | Take medication for 21 days (Yihuo 0.2g bid+ Jin Bifid2g tid) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diarrhea grading | Score according to the diarrhea grading:grading score: 0(None);1(Increased bowel movements < 4 times per day compared to before treatment); 2(Increased bowel movements 4 to 6 times/day or night compared to before treatment);3( Increased number of stools ≥ 7 times/day compared with before treatment, fecal incontinence, severe abdominal pain or fecal incontinence, affecting daily activities and requiring hospitalization); 4(life-threatening (e.g. circulatory failure));5(Death). | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time of the first occurrence of diarrhea | The median time of the first occurrence of diarrhea | 28 days |
| Duration of diarrhea | The median duration of diarrhea |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Fei, MD | Contact | +86-13711277870 | xufei@sysucc.org.cn | |
| Jiang Kuikui, MD | Contact | +86-15210589011 | jiangkk@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| 28 days |
| Time of the first occurrence of grade 3 diarrhea | The median time of the first occurrence of grade 3 diarrhea | 28 days |
| Duration of grade 3 diarrhea | The median duration of grade 3 diarrhea | 28 days |
| Adverse events | Occurrence of other adverse events | 28 days |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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