Cancer (Solid Tumors), Cisplatin, Olanzapine, Vomiting
Conditions
Keywords
cisplatin, chemotherapy induced nausea vomiting, dexamethasone sparing, olanzapine
Brief summary
A phase II study evaluating dexamethasone sparing regimen with olanzapine and palonosetron for patients receiving high dose cisplatin to prevent chemotherapy induced nausea and vomiting
Interventions
DRUGdexamethasone sparing
omit dexamethasone on day 2-4
Sponsors
Mahidol University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologically confirmed solid malignancy * scheduled for first cycle of cisplatin at dosage of at least 50 mg/m2
Exclusion criteria
* pregnancy * pelvic or abdominal radiation within 4 weeks * uncontrolled brain metastasis * other moderate or high emetic risk chemotherapy on day 2-5 * untreated gut obstruction * known allergy or severe adverse effect from palonosetron or olanzapine * AST/ ALT \> 2.5x or serum creatinine clearance less than 50 ml/min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete response rate | 5 days after receiving chemotherapy | no vomiting and no rescue therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| no -nausea rate | 5 days after receiving chemotherapy | no nausea symptom |
| degree of nausea vomiting | 5 days after receiving chemotherapy | grading of nausea vomiting |
| adverse effects | 5 days after receiving chemotherapy | adverse effects |
| rescue therapy | 5 days after chemotherapy | additional treatment for nausea or vomiting |
Countries
Thailand
Contacts
CONTACTSuthinee Ithimakin
Outcome results
None listed