Evaluation of the efficacy and safety of 5mg olanzapine combined with aprepitant, granisetron and dexamethasone to prevent carboplatin-induced nausea and vomiting in gynecologic cancer patients: a multicenter phase 2 study.
- Conditions
- gynecologic cancer
- Registration Number
- JPRN-UMIN000031646
- Lead Sponsor
- Gifu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 60
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 with unstable angina, ischemic heart disease, cerebral hemorrhage or apoplexy, active gastric or duodenal ulcer within 6 months prior to enrollment. 5. Patients who have convulsive disorders requiring anticonvulsants therapy 6. Patients with ascites effusion requiring paracentesis 7. Patients who have gastrointestinal obstruction 8.Pregnant, breastfeeding or expecting women or who do not wish to use contraception 9. Patients who have psychosis or psychiatric symptoms that interferes with daily life 10. Patient who received abdominal or pelvic irradiation within 6 days prior to enrollment 11. Patients who had diabetes mellitus 12. Habitual smoker at enrollment 13. Other patients who are judged to be inappropriate for the study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response (no emesis, no rescue medication) rate within 120 hours from the start of CBDCA administration.
- Secondary Outcome Measures
Name Time Method 1. Complete response (no emesis, no rescue medication) rate within 168 hours from the start of CBDCA administration. 2. Complete response rate during the acute (0-24h) phase. 3. Complete response rate during the delayed (24-120h or 24-168h) phase. 4. Complete control (no emetic episodes, no rescue medication use, and no more than mild nausea) rate for the acute, delayed and overall phases. 5. Total control rate (no emetic episodes, no rescue medication use, and no nausea) rate for the acute, delayed and overall phases. 6. Severity of nausea. 7. Severity of anorexia. 8. Severity of sleepiness and the impact on life 9. Adverse event