Prospective Study Evaluating Efficacy and Safety of Olanzapine and Aprepitant for Cisplatin-induced Nausea and Vomiting in Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma
Phase 2
- Conditions
- Hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000042360
- Lead Sponsor
- Department of Gastroenterology and Hepatology, Kurashiki Central Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1) pregnant, possibly pregnant or breastfeeding 2) regular use of olanzapine or other antipsychotic drugs 3) previous participation in this study 4) moderate or severe (NRS 4 or more) nausea 5) considered not appropriate for participating in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response (CR) rate within 120 hours in patients treated with olanzapine
- Secondary Outcome Measures
Name Time Method 1) CR rate, complete control (CC) rate and total control (TC) rate within 24 hours 2) CR rate, CC rate and TC rate within 24-120 hours 3) Numerical rating scale scores of nausea, vomiting and anorexia on day 1-6 4) Frequency of vomiting within 120 hours 5) Frequency of rescue antiemetic treatment within 120 hours 6) Frequency, severity and timing of adverse events due to antiemetic treatment 7) Child-Pugh score and ALBI score at 2 weeks and 1 month after treatment