Nausea and vomiting
Conditions
Interventions
Control group:Olanzapine 5 mg administered 1 hour before chemotherapy, in combination with netupitant-palonosetron and dexamethasone
Intervention group:Olanzapine 5 mg administered at bedtime the night before chemotherapy, in combination with netupitant-palonosetron and dexamethasone.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Pathologic diagnosis of solid tumors; Age 18-65 years old, gender is not limited; Patients who are about to receive chemotherapy with NCCN, CSCO (Chinese Society of Clinical Oncology) and other guidelines for chemotherapy drugs with a risk level of medium and high emetic drug regimens and have not undergone chemotherapy before; ECOG PS score =1500 cells/µL, platelet >=80000 cells/µL, and hemoglobin >=9.0 g/dL; serum creatinine <=1.5×ULN; ALT and AST < = 2.5× ULN (ALT and AST < = 5×ULN) and bilirubin <=1.5×ULN; Non-surgically sterilized female patients of childbearing potential must have a negative serum or urine HCG test result within 7 days prior to study enrollment and be willing to use appropriate methods of contraception for the duration of the trial; Able to read comprehension and complete scales independently; Voluntarily participate.
Exclusion criteria
Exclusion criteria: lactating or pregnant women; Planned concurrent radiotherapy or received abdominal radiotherapy 1 week prior to enrollment; History of hypersensitivity to any of the investigational drugs or similar compounds; Chemotherapy regimens include paclitaxel (requiring dexamethasone pretreatment); Are receiving anticonvulsant medication or fluoroquinolone antibiotics; Use of antiemetics or drugs with antiemetic effects within 48 hours prior to enrollment, including but not limited to NK-1RA, 5-HT3RA, dexamethasone, dopamine receptor antagonists, antihistamines, benzodiazepines, domperidone, thalidomide, etc.; Use of opioids or antipsychotics within 48 hours prior to enrollment; Symptomatic brain metastases or primary intracranial tumors; Presence of cognitive dysfunction; Suffering from psychiatric illness or receiving antipsychotic medication; History of cardiac disease, cardiac arrhythmia, uncontrolled heart failure, or acute myocardial infarction within the past 6 months; gastrointestinal obstruction or ascites effusion requiring management; Active infection, such as bacterial, fungal, viral infection, HIV infection, hepatitis B virus DNA quantification >=1×10³ copies/mL or positive hepatitis C virus antibody, active tuberculosis, etc.; Uncontrolled diabetes mellitus; Pain has not been fully controlled or the gastrointestinal response of painkillers has not been controlled; Receiving any systemic glucocorticoids other than the dose specified in the protocol for 1 week prior to or after enrollment (topical and inhaled glucocorticoids are allowed); nausea and vomiting 24 hours before starting chemotherapy; Presence of other factors that in the opinion of the investigator is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of daytime somnolence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antiemetic effect; | — |
Countries
China
Contacts
Public ContactYao Tiao Deng
West China Hospital, Sichuan University
Outcome results
None listed