Chemotherapy-induced nausea andvomiting
Conditions
Interventions
A:Day 1 palonosetron+dexamethasone+aprepitant, Day 2~4 dexamethasone+aprepitant
B:Day 1 tropisetron+dexamethasone+aprepitant, Day 2~4 dexamethasone+aprepitant
C:Day 1 palonosetron+dexamethasone, Day 2~4 dexamethasone
D:Day 1 palonosetron+dexamethasone, Day 2~4 dexamethasone+metoclopramide
Sponsors
Guangzhou General Hospitol of Guangzhou Military Command PLA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. age >=18 years old; 2. historical or cytological confirmation of solid malignancy; 3. naive to chemotherapy andscheduled to receive their first dose of an HEC regimen for treatment(day 1 only); 4. no serious hematopoietic dysfunction, heart, lung, liver, kidney dysfunction and immune deficiency, the blood routine examination, liver and kidney function is normal: WBC more than 3 500/uL, haemoglobin more than 9g/dL(without blood transfusion), Platelets more than 100000/uL, total bilirubin more than 1.5*upper limit of normal, AST (SGOT)/ALT (SGPT) less than 2.5*upper limit of normal, creatinine more than 1.5*upper limit of normal; 5. Eastern Cooperative Oncology Group (ECOG) performance status <=2; 6. accepted to trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. planned to receive chemotherapy from day 2-8; 2. experienced any vomiting within 24 h before day 1; 3. clinical evidence of bowel obstruction or symptomatic brain tumor; 4. taking systemic corticosteroid therapy at any dose and benzodiazepines (unless administered at night for sedation); 5. radiotherapy; 6. pregnant women or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate;number of emetic episodes;severity of nausea; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactWeimin Zhang
Outcome results
None listed