chemotherapy-induced nausea and vomiting
Conditions
Interventions
A-B Group:Treat by A regimen (palonosetron 0.25mg*d1, d3+dexamethasone 10mg*d1, 5mg*d2-5) in the first cycle
then treat by B regimen (tropisetron 5mg*d1-3/5+dexamethasone 10mg*d1, 5mg*d2-5) in the second cycle
B-A Group:Treat by B regimen (tropisetron 5mg*d1-3/5+dexamethasone 10mg*d1, 5mg*d2-5) in the first cycle
then treat by A regimen (palonosetron 0.25mg*d1, d3+dexamethasone 10mg*d1, 5mg*d2-5) in the second cycle
Sponsors
The Affiliated Tumor Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patient aged 18 to 70 years, male or females; 2. Patient with ECOG = 2; 3. Patient with histologically or cytologically confirmed malignant tumor; 4. Patient willing to accept chemotherapy and tolerated two cycles of chemotherapy at least; 5. Regimens of chemotherapy must be the standard regimens recommended in domestic and international clinical practice guidelines for relevant malignant tumor; 6. At least one chemotherapeutic with high emetic risk contained in the chemotherapy regimen ,like Cisplatin, Doxorubicin=60 mg/ m2, Epirubicin>90 mg/ m2, Ifosfamide=2 g/m2, used for 3 to 5days; 7. Normal function of major organs should meet the following criteria: (1) the blood routine examination must be in accordance with standard: Hb=90g/L, WBC=3.0×10^9/L, ANC=1.5×10^9/L, PLT=80×10^9/L; TBIL=1.5×ULN (higher than the normal limit), ALT, AST=2.5×ULN(if has liver metastasis ALT and AST=5×ULN); Serum Cr=1×ULN, endogenous creatinine clearance>50 ml/min (Cockcroft-Gault formula); 8. Last cycle of chemotherapy was completed =3 weeks prior to baseline; 9. Women of childbearing age are willing to using appropriate methods of contraception during the test and 8 weeks after having the last experimental drug, and should have a pregnancy check before test if necessary, the result should be negative; 10. Patient were willing to join in this study, sign the informed consent, good adherence, and cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing female patient; need radiotherapy during our study going on; 2. Patient with gastrointestinal tract obstruction; 3. Patient with seriously heart disease, liver and kidney diseases, or metabolic dysfunction; 4. Patient with epilepsy, or using psychiatric drugs or sedative; 5. Patient Used antiemetic within 24 hours of starting the study treatment, or vomited before chemotherapy; 6. Patient with metastatic brain tumor, vomiting because of intracranial hypertension; 7. Patient with irritability of 5-HT3 receptor antagonist; 8. Patient with Contraindications on chemotherapy; 9. Being or 4 weeks prior to the starting of the study involved in other drug clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response of delayed chemotherapy-induced nausea and vomiting; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response of acute chemotherapy-induced nausea and vomiting;Complete response of overall chemotherapy-induced nausea and vomiting; | — |
Countries
China
Contacts
Public ContactWeimin Xie
The Affiliated Tumor Hospital of Guangxi Medical University
Outcome results
None listed