A double-blind randomized phase II study of olanzapine 10mg versus 5mg for highly emetogenic chemotherapy-induced nausea and vomiting.
- Conditions
- Malignant solid tumor
- Registration Number
- JPRN-UMIN000014214
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 150
Not provided
1. history of hypersensitivity or allergy for study drugs or similar compounds. 2. patients who do not have enough general condition to the antineoplastic agents treatment. 3. symptomatic brain metastasis. 4. patients who has a convulsive disorders that need anticonvulsants therapy. 5. patients with a symptom who has ascites or pleural effusion that need puncture. 6. patients with obstruction of gastrointestinal tract, for example gastric outlet or ileus etc. 7. pregnant, breastfeeding or expecting woman. 8. patients enforced radiotherapy in the abdominal or pelvic field between 6 days before and 6 days after chemotherapy. 9. patients who take a medicine, for example, 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers, antihistamine drugs, benzodiazepine agents, etc within 48 hours prior to beginning chemotherapy. 10. patients who take opioids within 48 hours prior to beginning chemotherapy. 11. patient who is taking pimozide, clarithromycin, ketoconazole, itraconazole, barbiturate (primidone, phenobarbital), rifampicin, phenytoin, carbamazepine, fluvoxamine maleate, ciprofloxacin. 12. patients who take a medicine regularly, for example, 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers, antihistamine drugs, benzodiazepine, agents, etc. 13. patients who take adrenaline within 48 hours prior to beginning chemotherapy. 14. patients who had diabetes mellitus or past history of diabetes mellitus or HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1. 15. patients who cannot be hospitalized during 6 days (0-120 h). 16. 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 (24-120h) phase.
- Secondary Outcome Measures
Name Time Method 1. Complete response rate during the acute (0-24h) phase and for the overall (0-120h) phases. 2. Complete control (defined as no emetic episodes, no rescue medication use, and no more than mild nausea) rate for the overall (0-120h) phases and in daily periods. 3. Total control rate (defined as no emetic episodes, no rescue medication use, and no nausea) rate for the overall (0-120h) phases and in daily periods. 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 of sleepiness. 8. Adverse event.