Chemotherapy-induced nausea and vomiting in breast cancer
Conditions
Interventions
Experimental group:Standard triple antiemetic regimen combined with 5mg olanzapine tablets
control group:Accept the standard triple antiemetic regimen: ? Ondansetron tablets ? Aprepitant capsules ? Betamethasone sodium phosphate injection or Dexamethasone
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in this study, sign an informed consent form, and have good compliance; 2. women aged 18 to 75 years (including the threshold); 3. histologically or pathologically confirmed breast cancer; 4. receiving highly emetogenic chemotherapy (anthracycline combined with cyclophosphamide-based regimen or carboplatin-containing chemotherapy regimen) for the first time; 5. ECOG score of 0-1; 6. expected survival >= 12 weeks; 7. Normal function of major organs, i.e., the following criteria are met: (1) routine blood tests: hemoglobin >= 90g/L absolute neutrophil count >= 1.5×10^9/L platelets >= 100×10^9/L; (2) biochemical tests: ALT and AST = 50 mL/min; (3) Coagulation: activated partial thromboplastin time (APTT) <= 1.5 × ULN international normalised ratio (INR) <= 1.5 × ULN; 8. Adequate contraception is required throughout the study period for female patients of childbearing potential with a negative pregnancy test.
Exclusion criteria
Exclusion criteria: 1.Those who are allergic to Olanzapine Tablets, Aprepitant Capsules, Ondansetron Hydrochloride Tablets, Betamethasone Sodium Phosphate Injection, Dexamethasone Sodium Phosphate Injection, or drugs of the same class as the above-mentioned drugs; 2.Had nausea or vomiting for any reason within three days before enrollment; 3.with central nervous system diseases (such as brain metastases or epilepsy); 4.Unstable angina pectoris, myocardial infarction, cerebral hemorrhage, cerebral infarction, or active gastroduodenal ulcer within 6 months before enrollment; 5.Use of other antipsychotic drugs such as risperidone, quetiapine, clozapine, and phenothiazine within 30 days before enrollment, or administration of such drugs during the enrollment period; 6.Long-term hormone users (including those with immune system diseases such as systemic lupus erythematosus, adrenocortical hypofunction, etc.); 7.Having received other unmarketed clinical research drugs or treatments within 4 weeks before the first administration; 8.Patients who are pregnant, breastfeeding, may be pregnant, or are unwilling to take contraceptive measures; 9.The patient is mentally incompetent or suffers from severe emotional or mental disorders; 10.Having active infections (such as pneumonia, systemic fungal infections) or any uncontrolled diseases (such as diabetes, hypertension);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to treatment failure;Overall control rate;Complete remission rate in the acute phase;Average sleep efficiency;Complete remission rate in the delayed phase; | — |
Countries
China
Contacts
Public ContactLilin
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed