Diarrhea
Conditions
Interventions
intervention group:In the combination of traditional Chinese medicine prescriptions and Neratinib tablets, when diarrhea is uncontrollable, loperamide treatment is needed.
Sponsors
China Medical University Shengjing Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must meet all of the following inclusion criteria to be enrolled in this trial: 1) 18 to 75 years old subjects diagnosed with breast cancer; 2) Histologically confirmed HER2-positive [immunohistochemistry (IHC) score of 3 + confirmed by pathology laboratory or 2 + and positive in situ hybridization (ISH) test (ISH amplification rate = 2.0)] breast cancer subjects; 3) Breast cancer subjects requiring neratinib maleate tablets; 4) No history of allergy to traditional Chinese medicine; 5) Time interval from the last treatment: (a) If ER and/or PR are positive the subject will be given the corresponding endocrine therapy according to the treatment needs; (b) = 4 weeks if the last treatment is chemotherapy; 6) ECOG score: 0 or 1; 7) Absolute value of neutrophils = 1.5 x109/L platelets = 100 x109/L hemoglobin = 90 g/L; 8) Expected survival time = 3 months; 9) Voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: Anyone who has any of the following conditions cannot participate in this clinical study: 1) Previous treatment with neratinib maleate tablets and clear drug resistance; 2) History of allergy to Chinese medicine; 3) Underlying digestive tract diseases (ulcerative colitis etc.); 4) Other clinical trials have been conducted within 4 weeks before enrollment; 5) Uncontrollable or significant cardiovascular disease * including: A) Myocardial infarction within 12 months prior to screening; b) Uncontrollable angina pectoris within 6 months prior to screening; c) Congestive heart failure occurred within 6 months before screening or left ventricular ejection fraction (LVEF) 450ms at screening; f) History of cerebrovascular accident; g) Coronary heart disease that is symptomatic and requires medical treatment. 6) Cardiac B-ultrasound shows that the width of the fluid dark area in the end-diastolic pericardial cavity is = 10 mm; 7) Have received an organ transplant; 8) Before screening the toxicity of the original treatment plan has not recovered and there are still toxicity reactions above Grade 1; 9) Clinically obvious gastrointestinal abnormalities that may affect drug intake transport or absorption (such as inability to swallow chronic diarrhea intestinal obstruction etc.); 10) Have an active infection Active bacterial viral fungal mycobacterial parasitic or other infections (excluding nail bed fungal infections) within 4 weeks prior to screening or any major infectious event requiring intravenous antibiotic therapy or targeted antiviral therapy or hospitalization or persistent fever within 14 days prior to screening; 11) Less than 6 weeks after major organ surgery; 12) Abnormal liver function Total bilirubin > 1.5 times the upper limit of normal (total bilirubin in patients with Gilbert syndrome > 3 times the upper limit of normal); ALT/AST > 2.5 times the upper limit of normal in subjects without liver metastases ALT/AST > 5 times the upper limit of normal in subjects with liver metastases abnormal renal function (serum creatinine > 1.5 times the upper limit of normal); 13) Current or previous other malignant neoplasms; 14) Any mental or cognitive impairment that may limit their understanding of informed consent implementation and compliance with the study. 15) History of hypertension that cannot be stably controlled with medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diarrhea incidence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Whether there is statistical difference in syndrome differentiation;Cumulative duration of onset of Grade 3 diarrhea;Vomiting incidence;Quality of Life Scale Questionnaire Score Changes;Changes in the scoring of the tumor nutrition scale questionnaire;Time to first onset of diarrhea;Time to first onset of Grade 3 diarrhea;Incidence of nausea;Rate of constipation; | — |
Countries
China
Contacts
Public ContactKai Li
China Medical University Shengjing Hospital
Outcome results
None listed