colorectal cancer, lung cancer, breast cancer
Conditions
Interventions
dexamethasone day1-3 plus palonosetron
dexamethasone day1 plus palonosetron
Sponsors
Hokkaido University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age of 20 years or older 2)Diagnosis of malignancy 3)No systemic chemotherapy or prior low or minimal emetogenic chemotherapy 4)Moderately emetogenic chemotherapy is planned (The moderately emetogenic chemotherapy over 2 or more days is excluded) 5)Adequate bone marrow, lever and renal function 6)ECOG performance status of 0-2 7)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Serious or uncontrolled complication 2)Symptomatic or clinically suspected bone metastasis 3)Convulsive disorder needs anti-convulsant 4)Ascites fluid or pleural effusion needs paracentesis 5)Gastrointestinal obstruction 6)Vomiting and/or grade 2 or more nausea before chemotherapy 7)Hypersensitivity for 5-HT3 receptor antagonist 8)Hypersensitivity for dexamethasone 9)Pregnancy, lactation or who does not wish to contraception 10)History of palonosetorn administration 11)Capability or intention of cooperating 12)Participant in other anti-emetic trial 13)Undersirable for the patient to enter the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with complete response (no vomiting and no rescue medication) during day1-5 after moderately emetogenic chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Complete response rate (acute phase, late phase) 2)Complete control rate (no vomiting, no rescue medication and no or mild nausea) 3)Adverse events | — |
Countries
Japan
Contacts
Public ContactKenji Okita
Sapporo Medical University First Department of Surgery
Outcome results
None listed