chemotherapy-induced nausea and vomiting
Conditions
Interventions
Observation group a:. In the first cycle, 5mg olanzapine combined with triple antiemesis (Akynzeo combined with dexamethasone) was used to prevent nausea and vomiting after chemotherapy, and in the se
Observation group b:In the first cycle, 10mg olanzapine combined with triple antiemesis (Akynzeo combined with dexamethasone) was used to prevent nausea and vomiting after chemotherapy, and in the sec
Sponsors
Zhoukou Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients 2. =18 years old and =75 years old 3. Patients who receive the high-emetic-risk anticancer agents. 4. Patients who do not take a medicine, for example, 5HT3 receptor antagonists, NK1 receptor antagonists, or research related agents, within 3 weeks prior to enrollment. 5. No nausea or vomiting (grade II or above) within 72 hours before the start of chemotherapy. 6. Subject has Eastern Cooperative Oncology Group (ECOG) performance status = 2. 7. Subject has a life Expectation of at least 12 weeks. 8. At least 2 cycles of chemotherapy 9. In accordance with the indication of chemotherapy and basic requirements: Peripheral haematology: Hb =9.0g/dL; absolute neutrophil count =1.5×10^9/L; Platelet count =80×10^9/L Blood biochemistry: Total bilirubin < 1.25×ULN, ALT and AST = 2.5×ULN; If liver metastasis, ALT and AST < 5×ULN, Creatinine = 1×ULN, basic normal serum electrolyte (Na, Ka, Cl, Ca) Other important organs function normally. 10. Left ventricular ejection fraction =50% was detected by echocardiography
Exclusion criteria
Exclusion criteria: 1. Patients receiving moderate or high emetic radioation therapy within 1 week before chemotherapy or day 1 to 5 after chemotherapy. 2. Within 24 hours after chemotherapy, patients receiving any known or potential antiemetic agents and appearing symptoms vomiting, nausea, or mild nausea symptoms. 3. Serious cardiovascular, pulmonary disease, uncontrollable diabetes,active gastric ulcer, mental and other diseases. 4. Pregnant , breastfeeding and woman with child-bearing potential who are unwilling or unable to take effective contraceptive measures. 5. Drug addict or alcohol abuse. 6. Hypocalcemia or any other condition that may cause vomiting. 7. Patients has significant factors that affect the absorption of oral medication, such as chronic diarrhea or obstruction. 8. Subjects has hypersensitivity to netupitant/palonostron and Olanzapine capsules or any of its excipients. 9. Scheduled to receive any antiemetic agents within 3 weeks prior to day 1(including but not limited to: neurokin-1 (NK1) receptor antagonist, 5-HT3 receptor antagonists, olanzapine, scopolamine,et al.). 10. Scheduled to receive benzodiazepine, opioid or opioid derivatives (except midazolam, temazepam or triazolam)within 1 week before chemotherapy or day 1 to 5 after chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with complete response ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Patients With CR (acute and delayed);Percentage of patients with overall complete protection(OCP);Percentage of patients with overall total control (OTC);incidence of adverse events; | — |
Countries
China
Contacts
Public ContactKeyou Xu
Zhoukou Center Hospital
Outcome results
None listed