A randomized, double-blind, placebo-controlled phase III trial evaluating olanzapine 5mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy: J-SUPPORT 1604
- Conditions
- Malignant solid tumor
- Registration Number
- JPRN-UMIN000024676
- Lead Sponsor
- AMED (Japan Agency for Medical Research and Development)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 690
Not provided
1. History of hypersensitivity or allergy for study drugs or similar compounds. 2. Patients who need antiemetics at the enrollment. 3. Patients who start taking opioids within 48 hours prior to enrollment. 4. Patient who suffered from ischemic heart disease, cerebral hemorrhage or apoplexy, active gastric or duodenum ulcer within 6 months prior to enrollment. 5. Patients who has a convulsive disorders that need anticonvulsants therapy. 6. Patients with symptomatic ascites that need therapeutic drainage. 7. Patients with gastro-intestinal stenosis or obstruction. 8. Pregnant, breastfeeding or expecting woman. 9. Psychotic patients using antipsychotic drug. 10. Patient who received abdominal or pelvic irradiation within 6 days prior to enrollment or patients who receive abdominal or pelvic concurrent chemoradiotherapy. 11. Patients who had diabetes mellitus with use of antidiabetics and patients with HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1. 12. Patients who cannot be hospitalized during 6 days (0-120 h post-cisplatin administration). 13. Habitual smoker at the enrollment. 14. Patients judged by the investigator to be inappropriate for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response (CR: no emesis, no rescue medication) rate during the delayed phase (24-120h post-cisplatin administration).
- Secondary Outcome Measures
Name Time Method 1. Complete response rate during the acute (0-24h post-cisplatin administration) phase and for the overall phase (0-120h post-cisplatin administration). 2. Complete control (defined as no emetic episodes, no rescue medication, and no more than mild nausea) rate for the overall phases and in daily period. 3. Total control rate (defined as no emetic episodes, no rescue medication, and no nausea) rate for the overall phase and in daily period. 4. Time to treatment failure (i.e., time to first emetic episode or time to administration of rescue therapy, whichever occurred first). 5. Severity of nausea. 6. Severity of anorexia. 7. Severity and influence to daily life of sleepiness. 8. Adverse event.