The efficacy of combination antiemetic therapy with Olanzapine, Palonosetron and dexamethasone for the prevention of nausea and vomiting in patients receiving Moderately Emetogenic Chemotherapy
Phase 3
- Conditions
- gastric cancer, colorectal cancer
- Registration Number
- JPRN-UMIN000034383
- Lead Sponsor
- Osaka Medical Collage
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
"A history of allergy to drugs and similar compounds used in this study Patients who do not have general condition that can endure chemotherapy History of symptomatic brain metastasis or gastrointestinal obstruction nausea and vomiting within 24 hours before chemotherapy A history of diabetes, or HbA1c(NGSP)>6.5% or HbA1c(JDS)>6.1 %"
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response rate for the overall phase(0-120 hours), defined as no emetic episodes and no use of rescue medication
- Secondary Outcome Measures
Name Time Method "Complete response rate for the acute phase(0-24 hours), Complete response rate for the delayed phase(24-120 hours), Complete control rate for the acute, delayed and overall phase, Total control rate for the acute, delayed and overall phase, Degrees of nausea, appetite, Fatigue, hiccup and sleepiness, Number of vomiting, Presence or absence of use of olanzapine after the third course, Presence or absence of reduction of chemotherapy after the second course Frequency /severity of adverse events "