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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
Take medication for 21 days (Yihuo 0.2g bid+ Jin Bifid2g tid)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGDiarrhea 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).
Time frame: 28 days
Time of the first occurrence of diarrhea
The median time of the first occurrence of diarrhea
Time frame: 28 days
Duration of diarrhea
The median duration of diarrhea
Time frame: 28 days
Time of the first occurrence of grade 3 diarrhea
The median time of the first occurrence of grade 3 diarrhea
Time frame: 28 days
Duration of grade 3 diarrhea
The median duration of grade 3 diarrhea
Time frame: 28 days
Adverse events
Occurrence of other adverse events
Time frame: 28 days
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