Olanzapine versus Aprepitant in the triplet regimen for preventing highly emetogenic chemotherapy-induced nausea and vomiting: a double blind, non-inferiority, randomized phase 3 trial
Phase 3
Recruiting
- Conditions
- malignant tumor(only solid tumor)
- Registration Number
- JPRN-UMIN000034225
- Lead Sponsor
- Department of Surgery, Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Not provided
Exclusion Criteria
1) nausea or vomiting in the 24 hours before enrollment 2) past history of severe cognitive compromise and central nervous system disease 3) treatment with another antipsychotic agent within 30 days before enrollment 4) concurrent abdominal radiotherapy with chemotherapy 5) chronic alcoholism 6) cardiac arrhythmia and uncontrolled congestive heart failure within the previous 6 months 7) a patient with a bowel obstruction 8) a patient with pregnancy or a patient at risk of becoming pregnant 9) a patient with contraindications to aprepitant, olanzapine, granisetron and dexamethasone
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall complete response (no emetic episodes and no use of rescue medication) rate
- Secondary Outcome Measures
Name Time Method acute complete response rate(CR), delayed CR, vomiting rate, nausea rate, safety, adverse event and quality of life